Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)

Yonsei University

Status: Enrolling

Conditions: Chronic Kidney Diseases

Treatments: Drug: dual anti-platelet therapy 3months or less; Drug: dual anti-platelet therapy at least 6 months

Study type: Interventional

Funder types: Other

Identifiers

NCT04708587

1-2020-0073

Details and patient eligibility

About

The purpose of this prospective randomized clinical trial is to compare the clinical outcomes according to the duration of aspirin and clopidogrel or prasugrel with dual anti-platelet therapy after percutaneous coronary intervention in patients with advanced chronic kidney disease using a new generation drug eluting stents.

Full description

Prospective, open label, multicenter randomized clinical trial

Enrollment: 900 estimated patients

Sex: All

Ages: 19 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Over 19 years old
2. Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR <45 / <30 / <15 or dialysis)
3. Patients treated with a new generation drug eluting stent.
4. Patients who signed consent form

Exclusion criteria

1. Over 85 years old
2. Patients with high risk of bleeding 1) History of hemorrhagic stroke 2) Stroke, dementia or central nervous system damage within 1 year 3) Head trauma or brain surgery within 6 months 4) Tumor in the skull 5) If aortic dissection is suspected 6) Internal bleeding within 6 weeks 7) In case of active bleeding or bleeding disorder 8) In case of major surgery, trauma or bleeding within 3 weeks
3. Patients who need oral anticoagulant
4. Pregnant women or women of childbearing age
5. Life expectancy is less than 1 year
6. Patients with a history of intracranial bleeding
7. Moderate to severe hepatic impairment (Child-Pugh class B or C)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

dual anti-platelet therapy at least 6 months

Active Comparator group

Treatment:

Drug: dual anti-platelet therapy at least 6 months

dual anti-platelet therapy 3months or less

Experimental group

Treatment:

Drug: dual anti-platelet therapy 3months or less