Trial · NCT00699998
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
NCT00699998, Phase 3, Completed, Eli Lilly and Company; results first posted 2013-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects. Trials, record NCT00699998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00699998
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
- NCT number
- NCT00699998
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 9,326 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Acute Coronary Syndrome
- Interventions
- Clopidogrel, Prasugrel, Commercially-available Aspirin
- First posted
- 2008-06-18
- Last updated
- 2013-05-07
- Results first posted
- 2013-05-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke | Randomization through end of study (30-month visit) | The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal 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 a Composite Endpoint of CV Death and MI | Randomization through end of study (30-month visit) | The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) | Randomization through end of study (30-month visit) | The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke | Randomization through end of study (30-month visit) | The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. |
| Secondary | Platelet Aggregation Measures | Day 30 and 12 Months | Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization. |
| Secondary | Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) | Day 30 and 6 Months | Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. |
| Secondary | Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) | Day 30 and Month 6 | C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. |
| Secondary | Genotyping Related to Drug Metabolism | Baseline | Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100. |
| Secondary | Economic and Quality of Life Outcomes | Baseline and follow-up (24 months) | Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life. |
| Secondary | Summary of All Deaths | Randomization through end of study (30-month visit) | All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke | Randomization through end of study (30-month visit) | All randomized participants | percentage of participants with an event | NUMBER |
| SECONDARY | Percentage of Participants With a Composite Endpoint of CV Death and MI | Randomization through end of study (30-month visit) | All randomized participants | percentage of participants with an event | NUMBER |
| SECONDARY | Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) | Randomization through end of study (30-month visit) | All randomized participants | percentage of participants with an event | NUMBER |
| SECONDARY | Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke | Randomization through end of study (30-month visit) | All randomized participants | percentage of participants with an event | NUMBER |
| SECONDARY | Platelet Aggregation Measures | Day 30 and 12 Months | All participants who received at least 1 dose of study drug, and had a baseline and post-baseline PRU measurement at Day 30 or Month 12. | P2Y12 Reaction Units (PRU) | LEAST_SQUARES_MEAN |
| SECONDARY | Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) | Day 30 and 6 Months | All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline BNP measurement at Day 30 or 6 Months. | picograms per milliliter (pg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) | Day 30 and Month 6 | All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline CRP measurement at Day 30 or 6 Months. | milligrams per liter (mg/L) | GEOMETRIC_MEAN |
| SECONDARY | Genotyping Related to Drug Metabolism | Baseline | All randomized participants who provided a DNA sample. | percentage participants with geneotype | NUMBER |
| SECONDARY | Economic and Quality of Life Outcomes | Baseline and follow-up (24 months) | All randomized participants (combined \<75 years and 75 years and older) with SAQ data. | units on a scale | MEAN |
| SECONDARY | Summary of All Deaths | Randomization through end of study (30-month visit) | All randomized participants | participants | NUMBER |
Source ClinicalTrials.gov
Results by group252
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke | Prasugrel: <75 Years of Age | 10.06 | percentage of participants with an event | ||
| Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke | Prasugrel: 75 Years of Age or Older | 24.64 | percentage of participants with an event | ||
| Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke | Clopidogrel: <75 Years of Age | 10.96 | percentage of participants with an event | ||
| Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke | Clopidogrel: 75 Years of Age or Older | 24.13 | percentage of participants with an event | ||
| Percentage of Participants With a Composite Endpoint of CV Death and MI | Prasugrel: <75 Years of Age | 9.61 | percentage of participants with an event | ||
| Percentage of Participants With a Composite Endpoint of CV Death and MI | Prasugrel: 75 Years of Age or Older | 22.53 | percentage of participants with an event | ||
| Percentage of Participants With a Composite Endpoint of CV Death and MI | Clopidogrel: <75 Years of Age | 10.21 | percentage of participants with an event | ||
| Percentage of Participants With a Composite Endpoint of CV Death and MI | Clopidogrel: 75 Years of Age or Older | 22.69 | percentage of participants with an event | ||
| Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) | Prasugrel: <75 Years of Age | 12.13 | percentage of participants with an event | ||
| Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) | Prasugrel: 75 Years of Age or Older | 26.27 | percentage of participants with an event |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prasugrel: <75 Years of Age | 3,620 | |
| Overall Study | STARTED | Prasugrel: 75 Years of Age or Older | 1,043 | |
| Overall Study | STARTED | Clopidogrel: <75 Years of Age | 3,623 | |
| Overall Study | STARTED | Clopidogrel: 75 Years of Age or Older | 1,040 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Prasugrel: <75 Years of Age | 3,590 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Prasugrel: 75 Years of Age or Older | 1,033 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Clopidogrel: <75 Years of Age | 3,590 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Clopidogrel: 75 Years of Age or Older | 1,027 | |
| Overall Study | COMPLETED | Prasugrel: <75 Years of Age | 3,421 | |
| Overall Study | COMPLETED | Prasugrel: 75 Years of Age or Older | 957 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,534
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 | Prasugrel | 103 | 4,623 | 106 |
| other | Anaemia | Blood and lymphatic system disorders | Clopidogrel | 75 | 4,617 | 76 |
| other | Angina pectoris | Cardiac disorders | Prasugrel | 213 | 4,623 | 267 |
| other | Angina pectoris | Cardiac disorders | Clopidogrel | 250 | 4,617 | 320 |
| other | Atrial fibrillation | Cardiac disorders | Prasugrel | 93 | 4,623 | 102 |
| other | Atrial fibrillation | Cardiac disorders | Clopidogrel | 110 | 4,617 | 116 |
| other | Abdominal pain upper | Gastrointestinal disorders | Prasugrel | 41 | 4,623 | 44 |
| other | Abdominal pain upper | Gastrointestinal disorders | Clopidogrel | 49 | 4,617 | 51 |
| other | Constipation | Gastrointestinal disorders | Prasugrel | 71 | 4,623 | 76 |
| other | Constipation | Gastrointestinal disorders | Clopidogrel | 81 | 4,617 | 83 |
1 to 10 of 1,534Source ClinicalTrials.gov
See all 1,534 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 | 2,581 | 4,623 |
| Total, other adverse events | Clopidogrel | 2,494 | 4,617 |
| Total, serious adverse events | Prasugrel | 1,573 | 4,623 |
| Total, serious adverse events | Clopidogrel | 1,594 | 4,617 |
Source ClinicalTrials.gov
Papers24
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 |
|---|
| Prasugrel vs Clopidogrel: 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/NCT00699998
GET https://conductscience.org/api/trials/v1/NCT00699998/results?page=2