Extended Antiplatelet Therapy With Clopidogrel Alone Versus Clopidogrel Plus Aspirin After Completion of 9- to 12-month Dual Antiplatelet Therapy for ACS Patients With Both High Bleeding and Ischemic Risk.
Overview
- Phase
- Phase 4
- Intervention
- Clopidogrel
- Conditions
- Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage
- Sponsor
- Shenyang Northern Hospital
- Enrollment
- 7758
- Locations
- 13
- Primary Endpoint
- Clinical relevant bleeding events
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Han Yaling
Prof.
Shenyang Northern Hospital
Eligibility Criteria
Inclusion Criteria
- •ACS patients undergoing PCI (New-Generation DES) and finishing 9-12 months of DAPT
- •18 \~ 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:
- •≥75 years old
- •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:
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
Arms & Interventions
Clopidogrel monotherapy
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue clopidogrel monotherapy in the following 9 months.
Intervention: Clopidogrel
Clopidogrel plus aspirin
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue DAPT (aspirin+clopidogrel) in the following 9 months.
Intervention: Clopidogrel+aspirin
Outcomes
Primary Outcomes
Clinical relevant bleeding events
Time Frame: During 9-month follow up
defined as BARC type 2-5 bleeding events
Secondary Outcomes
- All bleeding events(During 9-month follow up)
- Major adverse cardiovascular and cerebrovascular events(MACCE)(During 9-month follow up)