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Dabigatran Versus Warfarin With NVAF Who Undergo PCI

NCT03536611 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1120

Last updated 2019-01-04

No results posted yet for this study

Summary

This study is to compare the efficacy and safety of dabigatran ethidium b.i.d.+ clopidogrel + ASA \[100 mg q.d. \*1 month\] and warfarin + clopidogrel + ASA \[100 mg, q.d.\*1 month\] in Chinese NVAF patients undergoing PCI with stenting (elective or due to ACS).

Conditions

Interventions

DRUG

dabigatran

dabigatran etexilate 110 mg bid + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by dabigatran 110mg bid + clopidogrel 75mg/d for at least 5 months

DRUG

warfarin

warfarin (according to clinical routine monitoring of INR, maintain the therapeutic range at 2.0-3.0) + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by warfarin + clopidogrel 75mg/d for at least 5 months

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Third Military Medical University

    collaborator OTHER

  • Shenyang Northern Hospital

    lead OTHER

Principal Investigators

  • zulu Wang, PhD · The General Hospital of Northern Theater Command

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03536611 on ClinicalTrials.gov