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Ethnic Differences and the Ischemia/Bleeding Risk of DAPT Duration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338335
Recruitment Status : Unknown
Verified February 2018 by Hyo-Soo Kim, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital

Brief Summary:
this study is an individual patient level meta-analysis of randomized clinical trials, to evaluate the influence of ethnicity, to study whether the relative tradeoff between ischemia and bleeding is distinct by ethnicity.

Condition or disease Intervention/treatment
Coronary Artery Disease Percutaneous Coronary Intervention Dual Antiplatelet Therapy Drug: prolonged DAPT

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 16000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Ethnic Differences in Ischemia/Bleeding Risk Tradeoff During Antiplatelet Therapy After Drug-eluting Stent Implantation
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding


Intervention Details:
  • Drug: prolonged DAPT
    Dual antiplatelet therapy will be prescribed for more than 12 months


Primary Outcome Measures :
  1. primary ischemic endpoint [ Time Frame: 2 years ]
    major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis

  2. primary bleeding endpoints [ Time Frame: 2 years ]
    major bleeding events


Secondary Outcome Measures :
  1. all-cause death [ Time Frame: 2 years ]
  2. cardiac death [ Time Frame: 2 years ]
  3. non-cardiac death [ Time Frame: 2 years ]
  4. any myocardial infarction [ Time Frame: 2 years ]
  5. any stroke [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
individual participant data (IPD) meta-analysis of randomized controlled trials designed to investigate the efficacy and safety of shorter duration of DAPT with a longer duration DAPT in patients with ischemic heart diseases.
Criteria

Inclusion Criteria:

  • patients enrolled in previous RCTs related to the duration of dural antiplatelet agent therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338335


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hyo-Soo Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03338335    
Other Study ID Numbers: DAPT
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This will be decided after the present analysis is completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Ischemia
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes