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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
7,758
Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)
Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)
Anhui Provincial Hospital
Hefei, Anhui, China
The Seventh Medical Center of Pla General Hospital
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital,Capital Medical University, word2
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital,Capital Medical University, word3
Beijing, Beijing Municipality, China
PLA Rocket Force Characteristic Medical Center
Beijing, Beijing Municipality, China
Clinical relevant bleeding events
defined as BARC type 2-5 bleeding events
Time frame: During 9-month follow up
All bleeding events
defined all BARC type 1-5 bleeding events
Time frame: During 9-month follow up
Major adverse cardiovascular and cerebrovascular events(MACCE)
defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization
Time frame: During 9-month follow up
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