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Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI

NCT04688723 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2021-04-30

No results posted yet for this study

Summary

A real world registry to compare dual therapy with Dabigatran/Ticagrelor to dual therapie with Dabigatran/Clopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS. Hypothesis: Dual therapy with Dabigatran/Ticagrelor will be non-inferior in reducing the risk of bleeding compared to Dual therapy with Dabigatran/Clopidogrel (RE-DUAL PCI trial based) in patients with an indication for NOAC undergoing PCI in the setting of ACS. Thromboembolic events, stent thrombosis and death will be evaluated for estimation of events between both groups. Data will be pooled for this secondary endpoint with data from the upcoming WOEST-3 trial to compare both treatments.

Conditions

Interventions

DRUG

Dabigatran + Ticagrelor

Patiënt interventional treatment, with dabigatran + ticagrelor (Brilique) 90mg twice daily up to 12 months.

DRUG

Dabigatran + clopidogrel

Patiënt interventional treatment, with dabigatran + clopidogrel (plavix) 75mg once daily up to 12 months.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2022-12-31
Completion
2023-07-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

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 NCT04688723 on ClinicalTrials.gov