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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
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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.
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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 
Overall Participants Analyzed 
[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 
[1] Race was self-reported
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 [1] 
[Units: Participants]
 1222   1210   360   350   3142 
[1]

“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”
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 [1] 
[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 
[1] "Unstable angina" includes unstable angina without reported elevation of cardiac enzymes
Any risk factor for stent thrombosis [1] 
[Units: Participants]
 2410   2389   568   569   5936 
[1]

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
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 [1] 
[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 
[1] 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
Modified ACC–AHA lesion class B2 or C [1] 
[Units: Lesions]
 2754   2643   440   450   6287 
[1] 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