Trial · NCT01088503
Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome
NCT01088503, Completed, Eli Lilly and Company; results first posted 2016-01-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome. Trials, record NCT01088503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01088503
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome
- NCT number
- NCT01088503
- Status
- Completed
- Enrollment
- 12,227 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Acute Coronary Syndrome
- Interventions
- ADP receptor inhibitors
- First posted
- 2010-03-17
- Last updated
- 2016-01-29
- Results first posted
- 2016-01-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | Baseline through 12 months | MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) \* 100. |
| Primary | Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Day 0 (study enrollment) | Factors are drug-eluting stent (DES) vs. bare metal stent (BMS) placement, other (no stent) vs. BMS, STEMI, other race, cardiogenic shock occurred within 24 hours, male, European Quality of Life Questionnaire-5 Dimension Health State Score (EQ-5D) - United States (US) Index =1 vs. \<1, married, diabetes, and other vs. BMS placement. The EQ-5D US index is a participant-rated, health-related, quality-of-life instrument based on US population. Scores range from -0.11 to 1.0 with 1.0 = perfect health. |
| Primary | Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin | Day 0 (study enrollment) | |
| Primary | Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index | Day 0 (study enrollment) | The Duke CAD Index is a validated composite measure of angiographic burden, which assigns prognostic weights 1 through 100. Higher scores indicate greater angiographic burden and are associated with poorer prognosis. |
| Secondary | Percentage of Participants With Cumulative Severe or Moderate Bleeding Events | Baseline, 1, 6, 12 and 15 months | Bleeding events were collected utilizing the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition of bleeding. Non-coronary artery bypass grafting (CABG)-related GUSTO severe or life-threatening bleeding is any intracranial hemorrhage (ICH) OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Non-CABG-related GUSTO moderate bleeding is any bleeding event resulting in the need for transfusion that is not considered a GUSTO severe or life-threatening bleed. Additional bleeding events are fatal bleeding or ICH, or any non -fatal surgical-related bleeding events leading to ≥4 units of red cell transfusion. Observed (unadjusted) percentages of participants with bleeding events, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events / number of participants treated) \* 100. |
| Secondary | Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years | Baseline through 12 months | MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participant = (number of participants with events / number of participants treated) \* 100. |
| Secondary | Percentage of Participants With MACE Over 1, 6 and 15 Months | Baseline through 1, 6 and 15 months | MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a MACE event. |
| Secondary | Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events | Baseline through 15 months | Academic Research Consortium (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 1 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. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with ST events are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a definite or probable ST event. |
| Secondary | Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness | 15 months |
Source ClinicalTrials.gov
Outcomes9
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 Major Adverse Cardiovascular Events (MACE) | Baseline through 12 months | Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis. | percentage of participants | NUMBER |
| PRIMARY | Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Day 0 (study enrollment) | All enrolled participants | participants | NUMBER |
| SECONDARY | Percentage of Participants With Cumulative Severe or Moderate Bleeding Events | Baseline, 1, 6, 12 and 15 months | Participants who were treated with prasugrel or clopidogrel. Participants with bleeding events dated prior to index PCI were excluded from the analysis. The analysis was based on the initial treatment assignment, regardless of whether or not the participants switched or discontinued that treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years | Baseline through 12 months | Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With MACE Over 1, 6 and 15 Months | Baseline through 1, 6 and 15 months | Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events | Baseline through 15 months | Participants who were treated with prasugrel or clopidogrel. | percentage of participants | NUMBER |
| SECONDARY | Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness | 15 months | Zero participants were analyzed. Exploratory analysis of resource use patterns, cumulative total medical costs, and cost effectiveness was dependent on effectiveness in the primary outcome. As there was no effectiveness on the primary outcome demonstrated, no analysis of these outcome measure was conducted. | ||
| PRIMARY | Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin | Day 0 (study enrollment) | All enrolled participants who had pre-procedure hemoglobin evaluation. | grams/deciliter (g/dL) | MEAN |
| PRIMARY | Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index | Day 0 (study enrollment) | All enrolled participants who had Duke CAD Index completed. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group46
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 Major Adverse Cardiovascular Events (MACE) | Prasugrel | 13.14 | 95% Confidence Interval 11.79 to 14.48 | percentage of participants | |
| Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | Clopidogrel | 17.12 | 95% Confidence Interval 16.25 to 17.98 | percentage of participants | |
| Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Prasugrel | Received DES | 2365 | participants | |
| Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Other | Received DES | 6282 | participants | |
| Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Prasugrel | Received only BMS | 672 | participants | |
| Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Other | Received only BMS | 2491 | participants | |
| Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Prasugrel | STEMI | 1831 | participants | |
| Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Other | STEMI | 4508 | participants | |
| Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Prasugrel | Other Race (Non-Caucasian) | 365 | participants | |
| Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment | Other | Other Race (Non-Caucasian) | 1049 | participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prasugrel | 3,123 | |
| Overall Study | STARTED | Clopidogrel | 8,846 | |
| Overall Study | STARTED | Ticlopidine/Ticagrelor | 258 | |
| Overall Study | COMPLETED | Prasugrel | 2,941 | |
| Overall Study | COMPLETED | Clopidogrel | 8,161 | |
| Overall Study | COMPLETED | Ticlopidine/Ticagrelor | 241 | |
| Overall Study | NOT COMPLETED | Prasugrel | 182 | |
| Overall Study | NOT COMPLETED | Clopidogrel | 685 | |
| Overall Study | NOT COMPLETED | Ticlopidine/Ticagrelor | 17 |
Source ClinicalTrials.gov
Adverse events339
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Prasugrel | 4 | 3,123 | 4 |
| serious | Acute coronary syndrome | Cardiac disorders | Prasugrel | 1 | 3,123 | 1 |
| serious | Acute myocardial infarction | Cardiac disorders | Prasugrel | 26 | 3,123 | 26 |
| serious | Angina pectoris | Cardiac disorders | Prasugrel | 23 | 3,123 | 23 |
| serious | Angina unstable | Cardiac disorders | Prasugrel | 24 | 3,123 | 25 |
| serious | Arrhythmia | Cardiac disorders | Prasugrel | 7 | 3,123 | 7 |
| serious | Arteriosclerosis coronary artery | Cardiac disorders | Prasugrel | 25 | 3,123 | 25 |
| serious | Atrial fibrillation | Cardiac disorders | Prasugrel | 9 | 3,123 | 11 |
| serious | Atrial flutter | Cardiac disorders | Prasugrel | 3 | 3,123 | 3 |
| serious | Atrioventricular block complete | Cardiac disorders | Prasugrel | 1 | 3,123 | 1 |
1 to 10 of 339Source ClinicalTrials.gov
See all 339 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prasugrel | ||
| Total, other adverse events | Prasugrel | 0 | 3,123 |
| Total, serious adverse events | Prasugrel | 865 | 3,123 |
Source ClinicalTrials.gov
Papers19
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01088503
GET https://conductscience.org/api/trials/v1/NCT01088503/results?page=2