Trial · NCT00097591
A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
NCT00097591, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention. Trials, record NCT00097591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00097591
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
- NCT number
- NCT00097591
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 13,619 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Coronary Arteriosclerosis, Acute Coronary Syndromes
- Interventions
- Prasugrel, Clopidogrel
- First posted
- 2004-11-25
- Last updated
- 2010-09-16
- Results first posted
- 2010-09-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Randomization up to 15 months | The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI). |
| Secondary | Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events | First dose of study drug up to 15 months (while at risk) | TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 gm/dL but \<5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal. |
| Secondary | Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR) | Randomization to 30 days; randomization to 90 days | The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods. |
| Secondary | Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Randomization to 30 days; randomization to 90 days | The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods. |
| Secondary | Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events | Randomization up to 15 months | The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population. |
| Secondary | Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Randomization up to 15 months | The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Randomization up to 15 months | Intention-to-treat (ITT) population consisting of all subjects with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) who may or may not have received study drug | Participants | NUMBER |
| SECONDARY | Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events | First dose of study drug up to 15 months (while at risk) | Treated subjects with adverse events were considered at risk from the first dose of study drug up through 7 days after permanent study drug discontinuation, or the subjects' discontinuation visit; or from randomization through 464 days, whichever is earlier. Adverse events classified as study drug related were included in the at risk set. | Participants | NUMBER |
| SECONDARY | Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR) | Randomization to 30 days; randomization to 90 days | Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug. | Participants | NUMBER |
| SECONDARY | Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Randomization to 30 days; randomization to 90 days | Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug. | Participants | NUMBER |
| SECONDARY | Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events | Randomization up to 15 months | Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug. | Participants | NUMBER |
| SECONDARY | Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Randomization up to 15 months | Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Prasugrel | UA/NSTEMI (n=5044, n=5030) | 469 | Participants | |
| Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Clopidogrel | UA/NSTEMI (n=5044, n=5030) | 565 | Participants | |
| Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Prasugrel | STEMI (n=1769, n=1765) | 174 | Participants | |
| Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Clopidogrel | STEMI (n=1769, n=1765) | 216 | Participants | |
| Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Prasugrel | All ACS (n=6813, n=6795) | 643 | Participants | |
| Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Clopidogrel | All ACS (n=6813, n=6795) | 781 | Participants | |
| Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events | Prasugrel | TIMI Major or Minor Bleeding | 303 | Participants | |
| Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events | Clopidogrel | TIMI Major or Minor Bleeding | 231 | Participants | |
| Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events | Prasugrel | TIMI Major Bleeding | 146 | Participants | |
| Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events | Clopidogrel | TIMI Major Bleeding | 111 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prasugrel | 6,813 | |
| Overall Study | STARTED | Clopidogrel | 6,795 | |
| Overall Study | COMPLETED | Prasugrel | 6,403 | |
| Overall Study | COMPLETED | Clopidogrel | 6,401 | |
| Overall Study | NOT COMPLETED | Prasugrel | 410 | |
| Overall Study | NOT COMPLETED | Clopidogrel | 394 |
Source ClinicalTrials.gov
Adverse events1,744
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 | Angina pectoris | Cardiac disorders | Prasugrel | 302 | 6,741 | 340 |
| other | Angina pectoris | Cardiac disorders | Clopidogrel | 334 | 6,716 | 382 |
| other | Nausea | Gastrointestinal disorders | Prasugrel | 308 | 6,741 | 327 |
| other | Nausea | Gastrointestinal disorders | Clopidogrel | 290 | 6,716 | 306 |
| other | Chest pain | General disorders | Prasugrel | 690 | 6,741 | 818 |
| other | Chest pain | General disorders | Clopidogrel | 643 | 6,716 | 771 |
| other | Fatigue | General disorders | Prasugrel | 249 | 6,741 | 261 |
| other | Fatigue | General disorders | Clopidogrel | 324 | 6,716 | 339 |
| other | Contusion | Injury, poisoning and procedural complications | Prasugrel | 464 | 6,741 | 529 |
| other | Contusion | Injury, poisoning and procedural complications | Clopidogrel | 262 | 6,716 | 302 |
1 to 10 of 1,744Source ClinicalTrials.gov
See all 1,744 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prasugrel | ||
| Total, all-cause mortality | Clopidogrel | ||
| Total, other adverse events | Prasugrel | 5,217 | 6,741 |
| Total, other adverse events | Clopidogrel | 5,187 | 6,716 |
| Total, serious adverse events | Prasugrel | 1,731 | 6,741 |
| Total, serious adverse events | Clopidogrel | 1,675 | 6,716 |
Source ClinicalTrials.gov
Papers18
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Prasugrel vs Clopidogrel: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events | Trial comparisons |
| Prasugrel vs Clopidogrel: Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke | Trial comparisons |
| Prasugrel vs Clopidogrel: serious adverse events | 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/NCT00097591
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