Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial

  • STATUS
    Recruiting
  • End date
    Sep 30, 2021
  • participants needed
    7700
  • sponsor
    Shenyang Northern Hospital
Updated on 26 January 2021

Summary

Current guidelines recommend that patients with ACS undergoing stent implantation might be offered extended DAPT treatment for up to 30 months if necessary.

Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among ACS patients with high-risk on ischemic and bleeding who received a new generation of DES and received 9 to 12 months of DAPT, and evaluated whether clopidogrel monotherapy reduce the risk of bleeding compared with clopidogrel plus ASA in the following 9 months and achieved non-inferior outcomes in preventing ischemic risk.

Description

Current guidelines recommend that patients with ACS undergoing stent implantation might be offered extended DAPT treatment for up to 30 months if necessary. For patients with high risk of both ischemic and hemorrhage, despite prolonged use of DAPT may bring antithrombotic benefit, it may also increase the risk of bleeding. There is an urgent need for specific guiding on intensive antiplatelet therapy in this population of patients to reduce the risk of ischemia and to avoid the risk of bleeding.

Previous studies have shown that, after 12 months of DAPT treatment, continuation of clopidogrel monotherapy may further reduce the risk of ischemia and bleeding compared with aspirin. Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among ACS patients with high-risk on ischemic and bleeding who received a new generation of DES and received 9 to 12 months of DAPT, and evaluated whether clopidogrel monotherapy reduce the risk of bleeding compared with clopidogrel plus ASA in the following 9 months and achieved non-inferior outcomes in preventing ischemic risk.

Details
Condition Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage
Treatment Clopidogrel, Clopidogrel+aspirin
Clinical Study IdentifierNCT03431142
SponsorShenyang Northern Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage?
Do you have any of these conditions: Do you have Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage??
ACS patients undergoing PCI (New-Generation DES) and finishing 9-12 months of DAPT
~ 85 years old adult patients
Patients under the age of 65 must meet at least one of the following clinical criteria of high bleeding risk and at least one of the following clinical criteria of high ischemic risk; Patients aged 65-75 must meet one of the following clinical criteria of either high bleeding risk or high ischemic risk
Clinical criteria of high bleeding risk
years old
female
Iron deficiency anemia
history of stroke (hemorrhagic or ischemic)
ongoing medical treatment of diabetes (oral hypoglycemic agents or subcutaneous insulin)
Chronic kidney disease (eGFR <60mL/min or creatinine clearance<60mL/min)
Clinical criteria of high ischemic risk
years old
Multiple coronary lesions
target lesions required for stent of total length> 30mm
Thrombotic target lesions
Bifurcation lesions are Medina 0, 1, 1 or 1, 1, and 1, with stents implanted in both main branch and side branch
Left main coronary artery (50%) or proximal LAD (70%) lesions
Calcified plaques requiring endovascular excision
acute coronary syndrome with troponin positive
Previous myocardial infarction, ischemic stroke, diagnosed peripheral arterial disease (PAD), or revascularization due to coronary artery disease (CAD) / PAD
recurrent myocardial infarction, revascularization, stent thrombosis, stroke in the last 9 months
ongoing medical treatment of diabetes (oral hypoglycemic agents or subcutaneous insulin)
Chronic kidney disease (eGFR<60 mL/min or creatinine clearance <60 mL/min)

Exclusion Criteria

Discontinuation or termination of DAPT treatment during the past 6 months due to adverse events (bleeding or ischemia) or other conditions
Surgery plan within 90 days
Coronary Revascularization (Surgical or Intervention) Program within 90 days
Dialysis-dependent renal failure
Moderate or severe hepatic insufficiency (2 times the upper limit of normal for ALT or AST)
Life expectancy <1 year
Unable or unwilling to provide informed consent
Women with childbearing potential
Platelet count <100000/mm3
Subjects undergoing warfarin or similar anticoagulant therapy
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