NCT03431142

Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7,758 (actual)
• Sponsor: Shenyang Northern Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage

Interventions

Type	Name	Description
DRUG	Clopidogrel	Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)
DRUG	Clopidogrel+aspirin	Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)

Timeline

• Start date: 2018-02-12
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2018-02-13
• Last updated: 2025-08-21

Locations

103 sites across 1 country: China