The Dual Antiplatelet Therapy Study (DAPT Study)

This study has been completed.
Sponsor:
Collaborators:
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis Corporation
Eli Lilly and Company
Daiichi Sankyo Inc.
Medtronic
Information provided by (Responsible Party):
Harvard Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT00977938
First received: September 14, 2009
Last updated: September 18, 2015
Last verified: September 2015
Results First Received: September 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: Placebo & Aspirin
Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between 08/13/2009 and 07/01/2011, a total of 25682 patients were enrolled into the DAPT Study either by HCRI (NCT00977938; 14491 pts) or from 1 of 4 PMS studies: Abbott Xience V US (NCT01106534; 2998 pts), Boston Scientific Liberté PAS (NCT00997503; 3904 pts), Cordis CYPRESS (NCT00954707; 2029 pts) and Medtronic EDUCATE (NCT01069003; 2260 pts).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
DES 30-month DAPT Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
DES 12-month DAPT Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
BMS 30-month DAPT Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
BMS 12-month DAPT Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).

Participant Flow for 2 periods

Period 1:   Treatment (12-30 mo. Post Procedure)
    DES 30-month DAPT     DES 12-month DAPT     BMS 30-month DAPT     BMS 12-month DAPT  
STARTED     5020     4941     842     845  
COMPLETED     4783     4716     796     784  
NOT COMPLETED     237     225     46     61  
Withdrawal by Subject                 132                 116                 13                 20  
Lost to Follow-up                 88                 91                 30                 37  
Other                 17                 18                 3                 4  

Period 2:   Observation (30-33 mo. Post Procedure)
    DES 30-month DAPT     DES 12-month DAPT     BMS 30-month DAPT     BMS 12-month DAPT  
STARTED     4783     4716     796     784  
COMPLETED     4732     4658     784     781  
NOT COMPLETED     51     58     12     3  
Withdrawal by Subject                 9                 12                 2                 0  
Lost to Follow-up                 34                 42                 10                 3  
Other                 8                 4                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DES 30-month DAPT Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
DES 12-month DAPT Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
BMS 30-month DAPT Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
BMS 12-month DAPT Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
Total Total of all reporting groups

Baseline Measures
    DES 30-month DAPT     DES 12-month DAPT     BMS 30-month DAPT     BMS 12-month DAPT     Total  
Number of Participants  
[units: participants]
  5020     4941     842     845     11648  
Age  
[units: years]
Mean (Standard Deviation)
  61.84  (10.18)     61.60  (10.12)     58.86  (10.54)     59.18  (11.07)     61.33  (10.29)  
Gender  
[units: participants]
         
Female     1242     1284     215     184     2925  
Male     3778     3657     627     661     8723  
Race/Ethnicity, Customized [1]
[units: participants]
         
American Indian or Alaska Native     17     41     0     2     60  
Asian     48     35     3     2     88  
Black or African American     252     253     38     33     576  
Native Hawaiian or Other Pacific Islander     13     9     1     1     24  
White     4480     4428     768     774     10450  
Other     108     106     20     23     257  
Region of Enrollment  
[units: participants]
         
North America     4502     4416     509     519     9946  
Europe     402     405     304     300     1411  
Australia     47     55     14     12     128  
New Zealand     69     65     15     14     163  
weight  
[units: kg]
Mean (Standard Deviation)
  91.49  (19.74)     91.52  (19.43)     87.99  (18.40)     88.54  (18.77)     91.04  (19.48)  
Body Mass Index (BMI)  
[units: kg/m2]
Mean (Standard Deviation)
  30.54  (5.79)     30.55  (5.77)     29.49  (5.18)     29.61  (5.55)     30.40  (5.73)  
Diabetes Mellitus  
[units: participants]
  1556     1481     181     173     3391  
Hypertension  
[units: participants]
  3796     3649     534     543     8522  
Current cigarette smoker or within past year [2]
[units: participants]
  1222     1210     360     350     3142  
Stroke/Transient Ischemic Attack (TIA)  
[units: participants]
  155     169     43     34     401  
Congestive heart failure  
[units: participants]
  238     223     35     28     524  
Peripheral arterial disease  
[units: participants]
  284     284     35     46     649  
Prior percutaneous coronary intervention (PCI)  
[units: participants]
  1518     1529     150     171     3368  
Prior coronary artery bypass graf (CABG)  
[units: participants]
  568     581     50     50     1249  
Prior myocardial infarction (MI)  
[units: participants]
  1092     1026     160     178     2456  
Indication for PCI [3]
[units: participants]
         
ST elevation MI (STEMI)     534     511     311     324     1680  
Non-ST elevation MI (NSTEMI)     776     767     184     169     1896  
Unstable angina     838     825     77     81     1821  
Stable angina     1882     1870     199     198     4149  
Other     990     968     71     73     2102  
Any risk factor for stent thrombosis [4]
[units: participants]
  2410     2389     568     569     5936  
Number of treated lesions (per-patient)  
[units: lesions]
Mean (Standard Deviation)
  1.30  (0.55)     1.29  (0.54)     1.16  (0.40)     1.17  (0.42)     1.28  (0.53)  
Number of treated vessels (per-patient)  
[units: vessels]
Mean (Standard Deviation)
  1.11  (0.33)     1.12  (0.34)     1.03  (0.18)     1.05  (0.23)     1.11  (0.32)  
Number of stents (per-patient)  
[units: stents]
Mean (Standard Deviation)
  1.47  (0.75)     1.45  (0.75)     1.32  (0.60)     1.32  (0.60)     1.44  (0.73)  
Minimum stent diameter (per-patient)  
[units: participants]
         
<3 mm     2341     2293     201     206     5041  
≥3 mm     2679     2648     641     639     6607  
Total stent length (per-patient)  
[units: mm]
Mean (Standard Deviation)
  27.70  (16.77)     27.43  (17.02)     23.96  (13.01)     23.85  (13.12)     27.04  (16.44)  
Treated Vessel [5]
[units: lesions]
         
Left main     55     55     0     1     111  
Left anterior descending (LAD)     2715     2586     308     306     5915  
Right coronary artery (RCA)     2153     2057     437     452     5099  
Circumflex     1473     1506     206     207     3392  
Venous graft     154     173     24     25     376  
Arterial graft     36     30     0     0     66  
Modified ACC–AHA lesion class B2 or C [6]
[units: lesions]
  2754     2643     440     450     6287  
[1] Race was self-reported
[2]

“Current cigarette smoker or within past year” was defined as follows:

  • HCRI DAPT: current cigarette smoker or within past year
  • Abbott Xience V: current tobacco user or former tobacco user within the past month
  • Boston Scientific Liberte PAS: smoking status of “current” from medical history
  • Cordis CYPRESS: smoking within 30 days
  • Medtronic EDUCATE: smoking/tobacco usage = “current” or “within last year”
[3] "Unstable angina" includes unstable angina without reported elevation of cardiac enzymes
[4]

Any clinical or lesion-related risk factors for stent thrombosis.

Clinical risk factors for stent thrombosis included:

  • Acute coronary syndrome (ACS) at presentation
  • ST elevation MI (STEMI) at presentation
  • Renal insufficiency or failure
  • Ejection fraction <30%.

Lesion-related risk factors for stent thrombosis included:

  • More than two vessels stented
  • >2 lesions per vessel
  • Lesion length ≥30 mm
  • Bifurcation lesion with side branch ≥2.5 mm
  • In-stent restenosis of a DES
  • Vein bypass graft
  • Unprotected left main
  • Thrombus containing lesion
  • Prior brachytherapy
[5] The 5,020 DES 30-month DAPT patients had a total of 6,594 lesions; The 4,941 DES 12-month DAPT patients had a total of 6,413 lesions; The 842 BMS 30-month DAPT patients had a total of 975 lesions; The 845 BMS 12-month DAPT patients had a total of 991 lesions
[6] The 5,020 DES 30-month DAPT patients had a total of 6,594 lesions; The 4,941 DES 12-month DAPT patients had a total of 6,413 lesions; The 842 BMS 30-month DAPT patients had a total of 975 lesions; The 845 BMS 12-month DAPT patients had a total of 991 lesions; The definitions of class B2 and class C lesions according to the modified ACC/AHA criteria



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT   [ Time Frame: 18 months (12-30 months post-index procedure) ]

2.  Primary:   Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT   [ Time Frame: 18 months (12-30 months post-index procedure) ]

3.  Primary:   GUSTO Severe or Moderate Bleeding - Randomized DES ITT   [ Time Frame: 18 months (12-30 months post-index procedure) ]

4.  Secondary:   MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS   [ Time Frame: 33 months (0-33 months post-index procedure) ]

5.  Secondary:   Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS   [ Time Frame: 33 months (0-33 months post-index procedure) ]

6.  Secondary:   MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT   [ Time Frame: 21 months (12-33 months post-index procedure) ]

7.  Secondary:   Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT   [ Time Frame: 21 months (12-33 months post-index procedure) ]

8.  Secondary:   GUSTO Severe or Moderate Bleeding - Randomized DES ITT   [ Time Frame: 21 months (12-33 months post-index procedure) ]

9.  Secondary:   MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT   [ Time Frame: 18 months (12-30 months post-index procedure) ]

10.  Secondary:   Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT   [ Time Frame: 18 months (12-30 months post-index procedure) ]

11.  Secondary:   GUSTO Severe or Moderate Bleeding - Randomized BMS ITT   [ Time Frame: 18 months (12-30 months post-index procedure) ]

12.  Secondary:   MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT   [ Time Frame: 21 months (12-33 months post-index procedure) ]

13.  Secondary:   Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT   [ Time Frame: 21 months (12-33 months post-index procedure) ]

14.  Secondary:   GUSTO Severe or Moderate Bleeding - Randomized BMS ITT   [ Time Frame: 21 months (12-33 months post-index procedure) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Priscilla Driscoll Shempp, Sr. Director Trial Design, Development and Strategy
Organization: Harvard Clinical Research Institute
phone: 617.307.5200
e-mail: pdriscoll@hcri.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Harvard Clinical Research Institute
ClinicalTrials.gov Identifier: NCT00977938     History of Changes
Other Study ID Numbers: HCRIG080186
Study First Received: September 14, 2009
Results First Received: September 18, 2015
Last Updated: September 18, 2015
Health Authority: United States: Food and Drug Administration