Trial · NCT00335452
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
NCT00335452, Phase 3, Completed, Sanofi; results first posted 2010-10-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS. Trials, record NCT00335452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00335452
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
- NCT number
- NCT00335452
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 25,086 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Acute Coronary Disease, Angina Unstable
- Interventions
- Clopidogrel, acetylsalicyclic acid (ASA)
- First posted
- 2006-06-09
- Last updated
- 2010-11-18
- Other registries' IDs
- eudract:2006-000313-38
- Results first posted
- 2010-10-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | 30 days | The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC). |
| Primary | First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison | 30 days | |
| Primary | First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level | 30 days | |
| Primary | First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup | 30 days | |
| Secondary | Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison | 30 days | Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC. |
| Secondary | Occurrence of Major Bleeding - ASA Dose Level Comparison | 30 days |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | 30 days | The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol. | participants | NUMBER |
| SECONDARY | Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison | 30 days | The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol. | participants | NUMBER |
| PRIMARY | First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison | 30 days | The analysis is on the the ASA treated population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS. | participants | NUMBER |
| PRIMARY | First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level | 30 days | The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol. | participants | NUMBER |
| PRIMARY | First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup | 30 days | The intent-to-treat (ITT) analysis is done on the randomized patients who underwent PCI during the study. | participants | NUMBER |
| SECONDARY | Occurrence of Major Bleeding - ASA Dose Level Comparison | 30 days | The analysis is on the treated patient population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS. | participants | NUMBER |
| POST_HOC | Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison | 30 days | The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol. | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | Clopidogrel 300/75/75 mg + ASA | CV death/MI/Stroke | 557 | participants | |
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | Clopidogrel 600/150/75 mg + ASA | CV death/MI/Stroke | 522 | participants | |
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | Clopidogrel 300/75/75 mg + ASA | - CV death | 222 | participants | |
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | Clopidogrel 600/150/75 mg + ASA | - CV death | 226 | participants | |
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | Clopidogrel 300/75/75 mg + ASA | - MI (fatal or not) | 274 | participants | |
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | Clopidogrel 600/150/75 mg + ASA | - MI (fatal or not) | 237 | participants | |
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | Clopidogrel 300/75/75 mg + ASA | - Stroke (fatal or not) | 61 | participants | |
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | Clopidogrel 600/150/75 mg + ASA | - Stroke (fatal or not) | 59 | participants | |
| Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison | Clopidogrel 300/75/75 mg + ASA | Major bleeding | 255 | participants | |
| Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison | Clopidogrel 600/150/75 mg + ASA | Major bleeding | 313 | participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clopidogrel 300/75/75 mg + ASA Low Dose | 6,312 | |
| Overall Study | STARTED | Clopidogrel 300/75/75 mg + ASA High Dose | 6,254 | |
| Overall Study | STARTED | Clopidogrel 600/150/75 mg + ASA Low Dose | 6,267 | |
| Overall Study | STARTED | Clopidogrel 600/150/75 mg + ASA High Dose | 6,253 | |
| Overall Study | TREATED WITH CLOPIDOGREL | Clopidogrel 300/75/75 mg + ASA Low Dose | 6,271 | |
| Overall Study | TREATED WITH CLOPIDOGREL | Clopidogrel 300/75/75 mg + ASA High Dose | 6,218 | |
| Overall Study | TREATED WITH CLOPIDOGREL | Clopidogrel 600/150/75 mg + ASA Low Dose | 6,228 | |
| Overall Study | TREATED WITH CLOPIDOGREL | Clopidogrel 600/150/75 mg + ASA High Dose | 6,217 | |
| Overall Study | TREATED WITH ASA | Clopidogrel 300/75/75 mg + ASA Low Dose | 6,302 | |
| Overall Study | TREATED WITH ASA | Clopidogrel 300/75/75 mg + ASA High Dose | 6,251 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,632
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 | Operative haemorrhage | Injury, poisoning and procedural complications | Clopidogrel 300/75/75 mg + ASA Low Dose | 39 | 6,312 | |
| serious | Operative haemorrhage | Injury, poisoning and procedural complications | Clopidogrel 300/75/75 mg + ASA High Dose | 50 | 6,254 | |
| serious | Operative haemorrhage | Injury, poisoning and procedural complications | Clopidogrel 600/150/75 mg + ASA Low Dose | 57 | 6,267 | |
| serious | Operative haemorrhage | Injury, poisoning and procedural complications | Clopidogrel 600/150/75 mg + ASA High Dose | 48 | 6,253 | |
| serious | Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Clopidogrel 300/75/75 mg + ASA Low Dose | 7 | 6,312 | |
| serious | Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Clopidogrel 300/75/75 mg + ASA High Dose | 8 | 6,254 | |
| serious | Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Clopidogrel 600/150/75 mg + ASA Low Dose | 7 | 6,267 | |
| serious | Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Clopidogrel 600/150/75 mg + ASA High Dose | 9 | 6,253 | |
| serious | Post procedural haemorrhage | Injury, poisoning and procedural complications | Clopidogrel 300/75/75 mg + ASA Low Dose | 12 | 6,312 | |
| serious | Post procedural haemorrhage | Injury, poisoning and procedural complications | Clopidogrel 300/75/75 mg + ASA High Dose | 16 | 6,254 |
1 to 10 of 1,632Source ClinicalTrials.gov
See all 1,632 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clopidogrel 300/75/75 mg + ASA Low Dose | ||
| Total, all-cause mortality | Clopidogrel 300/75/75 mg + ASA High Dose | ||
| Total, all-cause mortality | Clopidogrel 600/150/75 mg + ASA Low Dose | ||
| Total, all-cause mortality | Clopidogrel 600/150/75 mg + ASA High Dose | ||
| Total, other adverse events | Clopidogrel 300/75/75 mg + ASA Low Dose | 0 | 6,312 |
| Total, other adverse events | Clopidogrel 300/75/75 mg + ASA High Dose | 0 | 6,254 |
| Total, other adverse events | Clopidogrel 600/150/75 mg + ASA Low Dose | 0 | 6,267 |
| Total, other adverse events | Clopidogrel 600/150/75 mg + ASA High Dose | 0 | 6,253 |
| Total, serious adverse events | Clopidogrel 300/75/75 mg + ASA Low Dose | 322 | 6,312 |
| Total, serious adverse events | Clopidogrel 300/75/75 mg + ASA High Dose | 329 | 6,254 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
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/NCT00335452
GET https://conductscience.org/api/trials/v1/NCT00335452/results?page=2