CompletedPhase 4

The Dual Antiplatelet Therapy Study (DAPT Study)

United States, Australia, Czechia25,682 participantsStarted 2009-10

Plain-language summary

The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject is \> 18 years of age.
. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
. Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
. The subject has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent will be valid for the duration of the trial or until the subject withdraws.

Exclusion criteria

. Index procedure stent placement with stent diameter \<2.25 mm or \>4.0 mm.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

Timeframe: 18 months (12-30 months post-index procedure)

Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT

Timeframe: 18 months (12-30 months post-index procedure)

GUSTO Severe or Moderate Bleeding - Randomized DES ITT

Timeframe: 18 months (12-30 months post-index procedure)

Trial details

NCT IDNCT00977938

SponsorBaim Institute for Clinical Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2015-09-18

View on ClinicalTrials.gov More Coronary Artery Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject is \> 18 years of age.
. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
. Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
. The subject has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent will be valid for the duration of the trial or until the subject withdraws.

Exclusion criteria

. Index procedure stent placement with stent diameter \<2.25 mm or \>4.0 mm.

What they're measuring

MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

Timeframe: 18 months (12-30 months post-index procedure)

Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT

Timeframe: 18 months (12-30 months post-index procedure)

GUSTO Severe or Moderate Bleeding - Randomized DES ITT

Timeframe: 18 months (12-30 months post-index procedure)