Trial · NCT01015287
A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction
NCT01015287, Phase 3, Completed, Eli Lilly and Company; results first posted 2014-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction. Trials, record NCT01015287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01015287
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction
- NCT number
- NCT01015287
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,033 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Acute Coronary Syndromes
- Interventions
- Placebo, Prasugrel
- First posted
- 2009-11-18
- Last updated
- 2014-02-28
- Results first posted
- 2014-02-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout | First loading dose (LD) through 7 days after first LD | The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | First loading dose (LD) through 7 days after first LD | The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI) | Baseline, before PCI (not greater than 48 hours after randomization) | Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate. |
| Secondary | Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding | First loading dose (LD) through 7 days after first LD | The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout | First loading dose (LD) through 7 days after first LD | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | First loading dose (LD) through 7 days after first LD | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD) | First LD through 30 days after first LD | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI) | Baseline, before PCI (not greater than 48 hours after randomization) | All randomized participants who received at least 1 dose of study drug, had standardized troponin measured at baseline and before PCI (not greater than 48 hours after randomization). | ratio of assayed troponin/ULN | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding | First loading dose (LD) through 7 days after first LD | All randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout | Non Pre-treatment | 9.77 | percentage of participants | ||
| The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout | Pre-treatment | 9.97 | percentage of participants | ||
| Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Non Pre-treatment | 7.57 | percentage of participants | ||
| Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Pre-treatment | 8.64 | percentage of participants | ||
| Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD) | Non Pre-treatment | 7.21 | percentage of participants | ||
| Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD) | Pre-treatment | 7.07 | percentage of participants | ||
| Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD) | Non Pre-treatment | 6.51 | percentage of participants | ||
| Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD) | Pre-treatment | 6.63 | percentage of participants | ||
| Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD) | Non Pre-treatment | 7.31 | percentage of participants | ||
| Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD) | Pre-treatment | 7.71 | percentage of participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non Pre-treatment | 1,996 | |
| Overall Study | STARTED | Pre-treatment | 2,037 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Non Pre-treatment | 1,996 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Pre-treatment | 2,037 | |
| Overall Study | COMPLETED | Non Pre-treatment | 1,924 | |
| Overall Study | COMPLETED | Pre-treatment | 1,958 | |
| Overall Study | NOT COMPLETED | Non Pre-treatment | 72 | |
| Overall Study | NOT COMPLETED | Pre-treatment | 79 |
Source ClinicalTrials.gov
Adverse events1,514
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 | Anaemia | Blood and lymphatic system disorders | Non Pre-treatment | 10 | 1,996 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Pre-treatment | 17 | 2,037 | 17 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Non Pre-treatment | 1 | 1,996 | 1 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Pre-treatment | 0 | 2,037 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Non Pre-treatment | 0 | 1,996 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Pre-treatment | 1 | 2,037 | 1 |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Non Pre-treatment | 1 | 1,996 | 1 |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Pre-treatment | 0 | 2,037 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Non Pre-treatment | 1 | 1,996 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Pre-treatment | 2 | 2,037 | 2 |
1 to 10 of 1,514Source ClinicalTrials.gov
See all 1,514 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non Pre-treatment | ||
| Total, all-cause mortality | Pre-treatment | ||
| Total, other adverse events | Non Pre-treatment | 860 | 1,996 |
| Total, other adverse events | Pre-treatment | 876 | 2,037 |
| Total, serious adverse events | Non Pre-treatment | 167 | 1,996 |
| Total, serious adverse events | Pre-treatment | 206 | 2,037 |
Source ClinicalTrials.gov
Papers7
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Non Pre-treatment vs Pre-treatment: serious adverse events |
Source 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/NCT01015287
GET https://conductscience.org/api/trials/v1/NCT01015287/results?page=2