MedTrace Logo

Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial

NCT03431142 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7758

Last updated 2025-08-21

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Shenyang Northern Hospital

    lead OTHER

Principal Investigators

  • Yaling Han, MD · The General Hospital of Northern Theater Command

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431142 on ClinicalTrials.gov