Trial · NCT00391872
A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome
NCT00391872, Phase 3, Completed, AstraZeneca; results first posted 2012-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome. Trials, record NCT00391872. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00391872
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome
- NCT number
- NCT00391872
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 18,624 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Acute Coronary Syndrome
- Interventions
- Ticagrelor, Clopidogrel
- First posted
- 2006-10-25
- Last updated
- 2012-03-13
- Results first posted
- 2012-03-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke | Randomization up to 12 months | Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee. |
| Primary | Participants With Any Major Bleeding Event | First dosing up to 12 months | Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. |
| Secondary | Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization | Randomization up to 12 months | Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee. |
| Secondary | Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke | Randomization up to 12 months | Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee. |
| Secondary | Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events. | Randomization up to 12 months | Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated. |
| Secondary | Participants With MI Event | Randomization up to 12 months | Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. |
| Secondary | Participants With Death From Vascular Causes | Randomization up to 12 months | Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. |
| Secondary | Participants With Stroke | Randomization up to 12 months | Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. |
| Secondary | Participants With Death From Any Cause | Randomization up to 12 months | Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. |
| Secondary | Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding | First dosing up to 12 months | Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke | Randomization up to 12 months | The population was the full analysis set, which included all randomized patients | Participants | NUMBER |
| PRIMARY | Participants With Any Major Bleeding Event | First dosing up to 12 months | The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug | Participants | NUMBER |
| SECONDARY | Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization | Randomization up to 12 months | The subgroup of patients with intent for invasive management at randomization | Participants | NUMBER |
| SECONDARY | Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke | Randomization up to 12 months | The population was the full analysis set, which included all randomized patients | Participants | NUMBER |
| SECONDARY | Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events. | Randomization up to 12 months | The population was the full analysis set, which included all randomized patients | Participants | NUMBER |
| SECONDARY | Participants With MI Event | Randomization up to 12 months | The population was the full analysis set, which included all randomized patients | Participants | NUMBER |
| SECONDARY | Participants With Death From Vascular Causes | Randomization up to 12 months | The population was the full analysis set, which included all randomized patients | Participants | NUMBER |
| SECONDARY | Participants With Stroke | Randomization up to 12 months | The population was the full analysis set, which included all randomized patients | Participants | NUMBER |
| SECONDARY | Participants With Death From Any Cause | Randomization up to 12 months | The population was the full analysis set, which included all randomized patients | Participants | NUMBER |
| SECONDARY | Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding | First dosing up to 12 months | The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug | Participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke | TICAGRELOR | 864 | Participants | ||
| Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke | CLOPIDOGREL | 1014 | Participants | ||
| Participants With Any Major Bleeding Event | TICAGRELOR | 961 | Participants | ||
| Participants With Any Major Bleeding Event | CLOPIDOGREL | 929 | Participants | ||
| Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization | TICAGRELOR | 569 | Participants | ||
| Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization | CLOPIDOGREL | 668 | Participants | ||
| Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke | TICAGRELOR | 901 | Participants | ||
| Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke | CLOPIDOGREL | 1065 | Participants | ||
| Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events. | TICAGRELOR | 1290 | Participants | ||
| Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events. | CLOPIDOGREL | 1456 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TICAGRELOR | 9,333 | |
| Overall Study | STARTED | CLOPIDOGREL | 9,291 | |
| Overall Study | COMPLETED | TICAGRELOR | 9,026 | |
| Overall Study | COMPLETED | CLOPIDOGREL | 9,036 | |
| Overall Study | NOT COMPLETED | TICAGRELOR | 307 | |
| Overall Study | NOT COMPLETED | CLOPIDOGREL | 255 |
Source ClinicalTrials.gov
Adverse events2,020
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 | Headache | Nervous system disorders | TICAGRELOR | 621 | 9,333 | |
| other | Headache | Nervous system disorders | CLOPIDOGREL | 565 | 9,291 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | TICAGRELOR | 1,106 | 9,333 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | CLOPIDOGREL | 623 | 9,291 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | TICAGRELOR | 566 | 9,333 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | CLOPIDOGREL | 317 | 9,291 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | TICAGRELOR | 490 | 9,333 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | CLOPIDOGREL | 467 | 9,291 | |
| serious | Anaemia | Blood and lymphatic system disorders | TICAGRELOR | 35 | 9,333 | |
| serious | Anaemia | Blood and lymphatic system disorders | CLOPIDOGREL | 25 | 9,291 |
1 to 10 of 2,020Source ClinicalTrials.gov
See all 2,020 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TICAGRELOR | ||
| Total, all-cause mortality | CLOPIDOGREL | ||
| Total, other adverse events | TICAGRELOR | 2,278 | |
| Total, other adverse events | CLOPIDOGREL | 1,665 | |
| Total, serious adverse events | TICAGRELOR | 2,108 | |
| Total, serious adverse events | CLOPIDOGREL | 2,117 |
Source ClinicalTrials.gov
Papers62
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 comparisons16
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TICAGRELOR vs CLOPIDOGREL: Participants With Death From Vascular Causes | Trial comparisons |
TICAGRELOR vs CLOPIDOGREL: Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events. | Trial comparisons |
| TICAGRELOR vs CLOPIDOGREL: Participants With MI Event | Trial comparisons |
| TICAGRELOR vs CLOPIDOGREL: Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding | Trial comparisons |
| TICAGRELOR vs CLOPIDOGREL: Participants With Stroke | Trial comparisons |
| TICAGRELOR vs CLOPIDOGREL: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke | Trial comparisons |
| TICAGRELOR vs CLOPIDOGREL: Participants With Death From Any Cause | Trial comparisons |
| TICAGRELOR vs CLOPIDOGREL: Participants With Any Major Bleeding Event | Trial comparisons |
TICAGRELOR vs CLOPIDOGREL: Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization | Trial comparisons |
| TICAGRELOR vs CLOPIDOGREL: Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding | Trial comparisons |
1 to 10 of 16
See all 16 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/NCT00391872
GET https://conductscience.org/api/trials/v1/NCT00391872/results?page=2