Trial · NCT00305162
A Clinical Trial to Demonstrate the Efficacy of Cangrelor
NCT00305162, Phase 3, Terminated, The Medicines Company; results first posted 2014-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Trial to Demonstrate the Efficacy of Cangrelor. Trials, record NCT00305162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00305162
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial to Demonstrate the Efficacy of Cangrelor
- NCT number
- NCT00305162
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 8,882 participants, actual
- Lead sponsor
- The Medicines Company
- Conditions
- Myocardial Infarction (MI), Acute Coronary Syndromes (ACS)
- Interventions
- Cangrelor (P2Y12 inhibitor), clopidogrel (oral P2Y12 inhibitor), Placebo bolus & placebo infusion, Placebo capsules - end of infusion, Placebo capsules - as soon as possible after randomization
- First posted
- 2006-03-21
- Last updated
- 2014-05-08
- Results first posted
- 2014-04-23
- Limitations and caveats
Discontinued per prespecified stopping rules after the 70% interim analyses was conducted indicating the trial was not likely to meet the goal of demonstrating superiority to clopidogrel administered as usual care. No safety issues were identified.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) | randomization through 48 hours after randomization | (composite incidence) |
| Secondary | Incidence of All-cause Mortality and MI | randomization through 48 hours after randomization | (composite incidence) |
| Secondary | Individual Incidence of All-cause Mortality | randomization through 48 hours after randomization | |
| Secondary | Individual Incidence of IDR | randomization through 48 hours after randomization | |
| Secondary | Incidence of Stroke | randomization through 48 hours after randomization | Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as: * primary hemorrhagic - stroke with focal collections of intracranial blood * ischemic cerebral infarction - stroke without focal collections of intracranial blood * infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding * uncertain - no imaging or autopsy data are available. |
| Secondary | Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI | during index PCI | (a patient could have multiple procedural events) |
| Secondary | Incidence of All-cause Mortality, MI or IDR | randomization through 30 days after randomization | (composite incidence) |
| Secondary | Incidence of All-cause Mortality or MI | randomization through 30 days after randomization | (composite incidence) |
| Secondary | Incidence of All-cause Mortality | randomization through 30 days after randomization | |
| Secondary | Incidence of MI | randomization through 30 days after randomization |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) | randomization through 48 hours after randomization | mITT (excluding STEMI) | participants | NUMBER |
| SECONDARY | Incidence of All-cause Mortality and MI | randomization through 48 hours after randomization | mITT (excluding STEMI) | participants | NUMBER |
| SECONDARY | Individual Incidence of All-cause Mortality | randomization through 48 hours after randomization | mITT (excluding STEMI) | participants | NUMBER |
| SECONDARY | Individual Incidence of IDR | randomization through 48 hours after randomization | mITT (excluding STEMI) | participants | NUMBER |
| SECONDARY | Incidence of Stroke | randomization through 48 hours after randomization | mITT (excluding STEMI) | participants | NUMBER |
| SECONDARY | Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI | during index PCI | mITT (excluding STEMI) and based on available data | participants | NUMBER |
| SECONDARY | Incidence of All-cause Mortality, MI or IDR | randomization through 30 days after randomization | mITT (excluding STEMI), based on 30-day completers | participants | NUMBER |
| SECONDARY | Incidence of All-cause Mortality or MI | randomization through 30 days after randomization | mITT (excluding STEMI), based on 30-day completers | participants | NUMBER |
| SECONDARY | Incidence of All-cause Mortality | randomization through 30 days after randomization | mITT (excluding STEMI), based on 30-day completers | participants | NUMBER |
| SECONDARY | Incidence of MI | randomization through 30 days after randomization | mITT (excluding STEMI), based on 30-day completers | participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) | Cangrelor Arm | 290 | 0.89 to 1.24 | participants | |
| Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) | Clopidogrel Arm | 276 | 0.98 to 1.24 | participants | |
| Incidence of All-cause Mortality and MI | Cangrelor Arm | 285 | participants | ||
| Incidence of All-cause Mortality and MI | Clopidogrel Arm | 261 | participants | ||
| Individual Incidence of All-cause Mortality | Cangrelor Arm | 8 | participants | ||
| Individual Incidence of All-cause Mortality | Clopidogrel Arm | 5 | participants | ||
| Individual Incidence of IDR | Cangrelor Arm | 13 | participants | ||
| Individual Incidence of IDR | Clopidogrel Arm | 23 | participants | ||
| Incidence of Stroke | Cangrelor Arm | primary hemorrhagic | 1 | participants | |
| Incidence of Stroke | Clopidogrel Arm | primary hemorrhagic | 0 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 48 Hour Follow-up Period | STARTED | Cangrelor Arm | 4,435 | |
| 48 Hour Follow-up Period | STARTED | Clopidogrel Arm | 4,447 | |
| 48 Hour Follow-up Period | Intent-to-treat (ITT): SA/UA/NSTEMI | Cangrelor Arm | 3,933 | |
| 48 Hour Follow-up Period | Intent-to-treat (ITT): SA/UA/NSTEMI | Clopidogrel Arm | 3,924 | |
| 48 Hour Follow-up Period | Intent-to-treat (ITT): STEMI | Cangrelor Arm | 482 | |
| 48 Hour Follow-up Period | Intent-to-treat (ITT): STEMI | Clopidogrel Arm | 507 | |
| 48 Hour Follow-up Period | Modified ITT (mITT): SA/UA/NSTEMI | Cangrelor Arm | 3,889 | |
| 48 Hour Follow-up Period | Modified ITT (mITT): SA/UA/NSTEMI | Clopidogrel Arm | 3,865 | |
| 48 Hour Follow-up Period | Modified ITT (mITT): STEMI | Cangrelor Arm | 446 | |
| 48 Hour Follow-up Period | Modified ITT (mITT): STEMI | Clopidogrel Arm | 447 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events256
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 | chest pain | General disorders | Cangrelor Arm | 178 | 4,374 | |
| other | chest pain | General disorders | Clopidogrel Arm | 163 | 4,365 | |
| other | back pain | Musculoskeletal and connective tissue disorders | Cangrelor Arm | 167 | 4,374 | |
| other | back pain | Musculoskeletal and connective tissue disorders | Clopidogrel Arm | 164 | 4,365 | |
| other | nausea | Gastrointestinal disorders | Cangrelor Arm | 112 | 4,374 | |
| other | nausea | Gastrointestinal disorders | Clopidogrel Arm | 145 | 4,365 | |
| other | hypotension | Vascular disorders | Cangrelor Arm | 97 | 4,374 | |
| other | hypotension | Vascular disorders | Clopidogrel Arm | 89 | 4,365 | |
| other | headache | Nervous system disorders | Cangrelor Arm | 93 | 4,374 | |
| other | headache | Nervous system disorders | Clopidogrel Arm | 97 | 4,365 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cangrelor Arm | ||
| Total, all-cause mortality | Clopidogrel Arm | ||
| Total, other adverse events | Cangrelor Arm | 1,149 | 4,374 |
| Total, other adverse events | Clopidogrel Arm | 1,159 | 4,365 |
| Total, serious adverse events | Cangrelor Arm | 125 | 4,374 |
| Total, serious adverse events | Clopidogrel Arm | 127 | 4,365 |
Source ClinicalTrials.gov
Papers8
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 comparisons17
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cangrelor Arm vs Clopidogrel Arm: Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI | Trial comparisons |
| Cangrelor Arm vs Clopidogrel Arm: Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) | Trial comparisons |
| Cangrelor Arm vs Clopidogrel Arm: Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Trial comparisons |
| Cangrelor Arm vs Clopidogrel Arm: Incidence of All-cause Mortality, MI or IDR | Trial comparisons |
| Cangrelor Arm vs Clopidogrel Arm: Incidence of GUSTO Severe / Life-threatening Bleeding | Trial comparisons |
| Cangrelor Arm vs Clopidogrel Arm: Incidence of Stroke | Trial comparisons |
| Cangrelor Arm vs Clopidogrel Arm: Individual Incidence of All-cause Mortality | Trial comparisons |
| Cangrelor Arm vs Clopidogrel Arm: Incidence of ACUITY Major Bleeding | Trial comparisons |
| Cangrelor Arm vs Clopidogrel Arm: Incidence of All-cause Mortality and MI | Trial comparisons |
| Cangrelor Arm vs Clopidogrel Arm: Incidence of All-cause Mortality | Trial comparisons |
1 to 10 of 17
See all 17 trial comparisonsTests0
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/NCT00305162
GET https://conductscience.org/api/trials/v1/NCT00305162/results?page=2