Trial · NCT00357968
Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting
NCT00357968, Phase 2, Completed, Eli Lilly and Company; results first posted 2010-08-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting. Trials, record NCT00357968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00357968
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting
- NCT number
- NCT00357968
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 201 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Coronary Artery Disease
- Interventions
- Prasugrel, Clopidogrel, Placebo for Prasugrel, Placebo for Clopidogrel
- First posted
- 2006-07-28
- Last updated
- 2010-08-31
- Results first posted
- 2010-08-09
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose | 6 hours after loading dose | IPA was defined as (1 - \[maximal platelet aggregation(MPA) at 6 hours after study drug treatment\]/\[MPA before drug treatment\]) x 100. |
| Primary | Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment | after 14 days of maintenance dosing | Measures IPA during maintenance dosing before and after cross-over for each therapy. IPA was defined as (1 - \[maximal platelet aggregation(MPA) at 14 days after study drug treatment\]/\[MPA before drug treatment\]) x 100. |
| Secondary | Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose | 2 hours after loading dose | IPA was defined as (1 - \[maximal platelet aggregation (MPA) at 2 hours after study drug treatment\]/\[MPA before drug treatment\]) x 100. |
| Secondary | Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase | after 14 days of treatment (before cross-over) | Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin \>=5 gm/dL. Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin \>=3 gm/dL but \<5 gm/dL. |
| Secondary | Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase | 14 days after cross-over | Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin \>=5 gm/dL. Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin \>=3 gm/dL but \<5 gm/dL. |
| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase | after 14 days of treatment (before cross-over) | Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization |
| Secondary | Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase | 14 days after cross-over | Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization |
| Secondary | Number of Hyporesponsive Participants at 6 Hours After the Loading Dose | 6 hours after loading dose | Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) \<20% |
| Secondary | Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase | From loading dose to day 15 | Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) \<20% |
| Secondary | Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase | 14 days after cross-over | Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) \<20% |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose | 6 hours after loading dose | Consists of all patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist, and had evaluable pre-treatment and 6 hour MPA measurements.~Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing. | percent inhibition | MEAN |
| PRIMARY | Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment | after 14 days of maintenance dosing | Includes patients who received a loading dose and underwent percutaneous coronary intervention (PCI) regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover) | percent inhibition | MEAN |
| SECONDARY | Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose | 2 hours after loading dose | Includes all patients who received a loading dose of study drug, did not receive a GP IIb/IIIa antagonist and had evaluable pretreatment and 2 hour MPA measurements. Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing. | percent inhibition | MEAN |
| SECONDARY | Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase | after 14 days of treatment (before cross-over) | Patients received a single loading dose and 14 days of maintenance therapy. Patients had not yet crossed-over to the alternate maintenance dose. | participants | NUMBER |
| SECONDARY | Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase | 14 days after cross-over | All patients who received a loading dose of study drug, received maintenance therapy for 14 days and then switched to the alternate maintenance therapy. | participants | NUMBER |
| SECONDARY | Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase | after 14 days of treatment (before cross-over) | Includes all patients who received a loading dose. Patients who underwent PCI also received 14 days of maintenance treatment. Patients had not yet crossed-over to the alternate maintenance treatment. | participants | NUMBER |
| SECONDARY | Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase | 14 days after cross-over | Includes all patients who received a loading dose and underwent PCI, received a maintenance dose for 14 days, and then crossed-over to the alternate therapy for an additional 14 days of maintenance dosing. | participants | NUMBER |
| SECONDARY | Number of Hyporesponsive Participants at 6 Hours After the Loading Dose | 6 hours after loading dose | Includes patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist and had evaluable pre-treatment, and 6 hour MPA measurements.~Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing. | participants | NUMBER |
| SECONDARY | Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase | From loading dose to day 15 | Includes patients who received a single loading dose and had evaluable MPA measures, regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients had received 14 days of maintenance treatment but had not crossed-over to the alternate maintenance treatment. | participants | NUMBER |
| SECONDARY | Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase | 14 days after cross-over | Includes patients who received a single loading dose and had evaluable MPA measures,regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients received 14 days of maintenance treatment and then crossed-over to the alternate maintenance treatment for 14 days. | participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose | Prasugrel | 74.81 | Standard Deviation 13.01 | percent inhibition | |
| Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose | Clopidogrel | 31.77 | Standard Deviation 21.07 | percent inhibition | |
| Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment | Prasugrel | 61.34 | Standard Deviation 17.84 | percent inhibition | |
| Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment | Clopidogrel | 46.06 | Standard Deviation 21.34 | percent inhibition | |
| Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose | Prasugrel | 64.54 | Standard Deviation 20.43 | percent inhibition | |
| Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose | Clopidogrel | 20.32 | Standard Deviation 20.22 | percent inhibition | |
| Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase | Prasugrel | 2 | participants | ||
| Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase | Clopidogrel | 0 | participants | ||
| Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase | Clopidogrel | 0 | participants | ||
| Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase | Prasugrel | 0 | participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Maintenance Dose Phase | STARTED | Prasugrel to Clopidogrel | 102 | |
| First Maintenance Dose Phase | STARTED | Clopidogrel to Prasugrel | 99 | |
| First Maintenance Dose Phase | Received Loading Dose | Prasugrel to Clopidogrel | 102 | |
| First Maintenance Dose Phase | Received Loading Dose | Clopidogrel to Prasugrel | 99 | |
| First Maintenance Dose Phase | Percutaneous Coronary Intervention (PCI) | Prasugrel to Clopidogrel | 55 | |
| First Maintenance Dose Phase | Percutaneous Coronary Intervention (PCI) | Clopidogrel to Prasugrel | 57 | |
| First Maintenance Dose Phase | Started Maintenance Dose | Prasugrel to Clopidogrel | 55 | |
| First Maintenance Dose Phase | Started Maintenance Dose | Clopidogrel to Prasugrel | 55 | |
| First Maintenance Dose Phase | COMPLETED | Prasugrel to Clopidogrel | 54 | |
| First Maintenance Dose Phase | COMPLETED | Clopidogrel to Prasugrel | 55 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events452
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Prasugrel Before Cross-over | 0 | 102 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Clopidogrel Before Cross-over | 1 | 99 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Prasugrel After Cross-over | 0 | 55 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Clopidogrel After Cross-over | 0 | 53 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Prasugrel Before Cross-over | 1 | 102 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Clopidogrel Before Cross-over | 0 | 99 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Prasugrel After Cross-over | 0 | 55 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Clopidogrel After Cross-over | 0 | 53 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Prasugrel Before Cross-over | 1 | 102 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Clopidogrel Before Cross-over | 0 | 99 | 0 |
1 to 10 of 452Source ClinicalTrials.gov
See all 452 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prasugrel Before Cross-over | ||
| Total, all-cause mortality | Clopidogrel Before Cross-over | ||
| Total, all-cause mortality | Prasugrel After Cross-over | ||
| Total, all-cause mortality | Clopidogrel After Cross-over | ||
| Total, other adverse events | Prasugrel Before Cross-over | 40 | 102 |
| Total, other adverse events | Clopidogrel Before Cross-over | 40 | 99 |
| Total, other adverse events | Prasugrel After Cross-over | 16 | 55 |
| Total, other adverse events | Clopidogrel After Cross-over | 12 | 53 |
| Total, serious adverse events | Prasugrel Before Cross-over | 8 | 102 |
| Total, serious adverse events | Clopidogrel Before Cross-over | 7 | 99 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prasugrel vs Clopidogrel: Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase | Trial comparisons |
Clopidogrel vs Prasugrel: Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase | Trial comparisons |
| Clopidogrel vs Prasugrel: Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase | Trial comparisons |
| Clopidogrel vs Prasugrel: Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase | Trial comparisons |
| Prasugrel vs Clopidogrel: Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase | Trial comparisons |
| Prasugrel vs Clopidogrel: Number of Hyporesponsive Participants at 6 Hours After the Loading Dose | Trial comparisons |
Prasugrel vs Clopidogrel: Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00357968
GET https://conductscience.org/api/trials/v1/NCT00357968/results?page=2