Trial · NCT00977938
The Dual Antiplatelet Therapy Study (DAPT Study)
NCT00977938, Phase 4, Completed, Baim Institute for Clinical Research; results first posted 2015-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Dual Antiplatelet Therapy Study (DAPT Study). Trials, record NCT00977938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00977938
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Dual Antiplatelet Therapy Study (DAPT Study)
- NCT number
- NCT00977938
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 25,682 participants, actual
- Lead sponsor
- Baim Institute for Clinical Research
- Conditions
- Coronary Artery Disease
- Interventions
- Placebo & Aspirin, Clopidogrel & Aspirin, Prasugrel & Aspirin
- First posted
- 2009-09-16
- Last updated
- 2017-06-09
- Results first posted
- 2015-10-22
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 18 months (12-30 months post-index procedure) | The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure. |
| Primary | Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 18 months (12-30 months post-index procedure) | The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions. |
| Primary | GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 18 months (12-30 months post-index procedure) | The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. |
| Secondary | MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS | 33 months (0-33 months post-index procedure) | Secondary powered endpoint |
| Secondary | Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS | 33 months (0-33 months post-index procedure) | Secondary powered endpoint |
| Secondary | MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 21 months (12-33 months post-index procedure) | |
| Secondary | Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 21 months (12-33 months post-index procedure) | ST was assessed according to the Academic Research Consortium (ARC) definitions. |
| Secondary | GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 21 months (12-33 months post-index procedure) | Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. |
| Secondary | MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT | 18 months (12-30 months post-index procedure) | |
| Secondary | Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT | 18 months (12-30 months post-index procedure) | ST was assessed according to the Academic Research Consortium (ARC) definitions. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 18 months (12-30 months post-index procedure) | All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier. | percentage of patients (KM estimate) | NUMBER |
| PRIMARY | Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 18 months (12-30 months post-index procedure) | All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier. | percentage of patients (KM estimate) | NUMBER |
| PRIMARY | GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 18 months (12-30 months post-index procedure) | Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days). | percentage of patients | NUMBER |
| SECONDARY | MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS | 33 months (0-33 months post-index procedure) | A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8. | percentage of patients | NUMBER |
| SECONDARY | Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS | 33 months (0-33 months post-index procedure) | A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8. | percentage of patients | NUMBER |
| SECONDARY | MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | 21 months (12-33 months post-index procedure) | All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier. | percentage of patients (KM estimate) | NUMBER |
| SECONDARY | Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | 21 months (12-33 months post-index procedure) | All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier. | percentage of patients (KM estimate) | NUMBER |
| SECONDARY | GUSTO Severe or Moderate Bleeding - Randomized DES ITT | 21 months (12-33 months post-index procedure) | Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days). | percentage of patients | NUMBER |
| SECONDARY | MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT | 18 months (12-30 months post-index procedure) | All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier. | percentage of patients (KM estimate) | NUMBER |
| SECONDARY | Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT | 18 months (12-30 months post-index procedure) | All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier. | percentage of patients (KM estimate) | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | DES 30-month DAPT | 4.34 | percentage of patients (KM estimate) | ||
| MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT | DES 12-month DAPT | 5.92 | percentage of patients (KM estimate) | ||
| Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | DES 30-month DAPT | 0.40 | percentage of patients (KM estimate) | ||
| Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT | DES 12-month DAPT | 1.35 | percentage of patients (KM estimate) | ||
| GUSTO Severe or Moderate Bleeding - Randomized DES ITT | DES 30-month DAPT | 2.53 | percentage of patients | ||
| GUSTO Severe or Moderate Bleeding - Randomized DES ITT | DES 12-month DAPT | 1.57 | percentage of patients | ||
| MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS | Propensity-matched DES | 11.37 | percentage of patients | ||
| MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS | Propensity-matched BMS | 13.24 | percentage of patients | ||
| Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS | Propensity-matched DES | 1.70 | percentage of patients | ||
| Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS | Propensity-matched BMS | 2.61 | percentage of patients |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment (12-30 mo. Post Procedure) | STARTED | DES 30-month DAPT | 5,020 | |
| Treatment (12-30 mo. Post Procedure) | STARTED | DES 12-month DAPT | 4,941 | |
| Treatment (12-30 mo. Post Procedure) | STARTED | BMS 30-month DAPT | 842 | |
| Treatment (12-30 mo. Post Procedure) | STARTED | BMS 12-month DAPT | 845 | |
| Treatment (12-30 mo. Post Procedure) | COMPLETED | DES 30-month DAPT | 4,783 | |
| Treatment (12-30 mo. Post Procedure) | COMPLETED | DES 12-month DAPT | 4,716 | |
| Treatment (12-30 mo. Post Procedure) | COMPLETED | BMS 30-month DAPT | 796 | |
| Treatment (12-30 mo. Post Procedure) | COMPLETED | BMS 12-month DAPT | 784 | |
| Treatment (12-30 mo. Post Procedure) | NOT COMPLETED | DES 30-month DAPT | 237 | |
| Treatment (12-30 mo. Post Procedure) | NOT COMPLETED | DES 12-month DAPT | 225 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events2,108
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 | AEs were not collected in the DAPT Trial | Cardiac disorders | HCRI DAPT - DES 30-month DAPT | 0 | 0 | 0 |
| other | AEs were not collected in the DAPT Trial | Cardiac disorders | HCRI DAPT - DES 12-month DAPT | 0 | 0 | 0 |
| other | AEs were not collected in the DAPT Trial | Cardiac disorders | HCRI DAPT - BMS 30-month DAPT | 0 | 0 | 0 |
| other | AEs were not collected in the DAPT Trial | Cardiac disorders | HCRI DAPT - BMS 12-month DAPT | 0 | 0 | 0 |
| serious | ANAEMIA | Blood and lymphatic system disorders | HCRI DAPT - DES 30-month DAPT | 12 | 2,642 | |
| serious | ANAEMIA | Blood and lymphatic system disorders | HCRI DAPT - DES 12-month DAPT | 9 | 2,634 | |
| serious | ANAEMIA | Blood and lymphatic system disorders | HCRI DAPT - BMS 30-month DAPT | 1 | 842 | |
| serious | ANAEMIA | Blood and lymphatic system disorders | HCRI DAPT - BMS 12-month DAPT | 1 | 845 | |
| serious | ANAEMIA OF CHRONIC DISEASE | Blood and lymphatic system disorders | HCRI DAPT - DES 30-month DAPT | 2 | 2,642 | |
| serious | ANAEMIA OF CHRONIC DISEASE | Blood and lymphatic system disorders | HCRI DAPT - DES 12-month DAPT | 0 | 2,634 |
1 to 10 of 2,108Source ClinicalTrials.gov
See all 2,108 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HCRI DAPT - DES 30-month DAPT | ||
| Total, all-cause mortality | HCRI DAPT - DES 12-month DAPT | ||
| Total, all-cause mortality | HCRI DAPT - BMS 30-month DAPT | ||
| Total, all-cause mortality | HCRI DAPT - BMS 12-month DAPT | ||
| Total, other adverse events | HCRI DAPT - DES 30-month DAPT | 0 | 0 |
| Total, other adverse events | HCRI DAPT - DES 12-month DAPT | 0 | 0 |
| Total, other adverse events | HCRI DAPT - BMS 30-month DAPT | 0 | 0 |
| Total, other adverse events | HCRI DAPT - BMS 12-month DAPT | 0 | 0 |
| Total, serious adverse events | HCRI DAPT - DES 30-month DAPT | 617 | 2,642 |
| Total, serious adverse events | HCRI DAPT - DES 12-month DAPT | 572 | 2,634 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers20
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/NCT00977938
GET https://conductscience.org/api/trials/v1/NCT00977938/results?page=2