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Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI (RE-DUAL PCI)

Primary Purpose

Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction

Status

Unknown status

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Dabigatran + Ticagrelor

Dabigatran + clopidogrel

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Permanent, persistent or paroxysmal atrial fibrillation are eligible.
PCI and successful stenting with DES for ACS (unstable angina pectoris, NSTEMI, STEMI)
Written informed consent.

Exclusion Criteria:

Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study
Glomerular filtration rate < 30 ml/min
Heart valve prosthesis (mechanical or biological)
Cardiogenic shock
Contra-indication for Dabigatran, Ticagrelor or Clopidogrel
- Liver dysfunction (ALAT, ASAT, Alkaline phosphatase > 3x upper limit of normal) or liver disease (like hepatitis A, B, C)
- Lesion or condition with a significant risk of serious bleeding, such as; current or recent gastrointestinal ulceration; malignant neoplasms with more bleeding risk; recent brain / spinal cord injury; recent surgery on the brain, spinal cord or eyes; recent or history of intracranial haemorrhage; oesophageal varices; arteriovenous malformations; vascular aneurysms; o severe intraspinal or intracerebral vascular abnormalities.
- comedication with cyclosporine, itraconazole, ketoconazole (systemic) and glecaprevir / pibrentasvir, dronedarone, rifampicine, carbamazepine, St. Jan's wort or phenytoin o Comedication with tacrolimus is not recommended.
Allergy to for Dabigatran, Ticagrelor or Clopidogrel
Pregnancy
Significant thrombocytopenia (platelet count < 50x10 9/L)
Major bleeding according to BARC ≥3 within the past 6 months.
Weight < 50 kg

Sites / Locations

Zuyderland MCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dabigatran/Clopidogrel

Dabigatran/Ticagrelor

Arm Description

Patiënt receive standard care, with dabigatran + clopidogrel 75mg once daily up to 12 months.

Patiënt receive standard care, with dabigatran + ticagrelor 90mg twice daily up to 12 months.

Outcomes

Primary Outcome Measures

Bleeding

Bleeding defined as BARC bleeding score ≥2

Secondary Outcome Measures

Myocardial Infarction

Cerebrovascular accident

Cerebrovascular accident, ischemic of haemorrhagic

Systemic Embolic Complications

Death

Combined endpoint of ischemic events

All secondary outcomes combined into one endpoint

Full Information

NCT ID

NCT04688723

First Posted

December 23, 2020

Last Updated

April 29, 2021

Sponsor

Zuyderland Medisch Centrum

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT04688723

Brief Title

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

Acronym

RE-DUAL PCI

Official Title

RE-DUAL PCI Real Life Registry Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 23, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zuyderland Medisch Centrum

Collaborators

Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

The REDUAL PCI Registry will we be an open-label multicenter registry based randomised controlled trial (RBRCT) within the ZON-HR collaboration in 4 of the 6 centers in the Netherlands: Maastricht Universitair Medisch Centrum (Maastricht), Zuyderland (Heerlen and Sittard), Vie Curi (Venlo) and Radboud Medisch Centrum (Nijmegen). Isala (Zwolle) and Canisius Wilhelmina ziekenhuis (Nijmegen) will not be part of this study. This study is Investigator initiated with an unrestricted grant from Boehringer Ingelheim (subsidising party). This study is also to be noted as a Post Authorisation Safety Study (PASS). Patients 1000 patients with an indication for NOAC, who underwent successful PCI with Drug Eluting Stent (DES) in the setting of ACS will be included and randomised at each of the 4 centers of the ZON-HR. After randomisation, patients will be treated with Dual therapy with Dabigatran/Clopidogrel or with Dabigatran/ Ticagrelor. A total of 1000 patients in 4 centers will be included: 250 patients in each center. In each center inclusion and randomisation will be executed within 48 hours after PCI. Inclusions are expected to be done within 1 year. After inclusion of the interventional (Dual therapy with Dabigatran/Ticagrelor) and control group (Dual therapy with Dabigatran/Clopidogrel), follow-up of 1 year is planned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dabigatran/Clopidogrel

Arm Type

Active Comparator

Arm Description

Patiënt receive standard care, with dabigatran + clopidogrel 75mg once daily up to 12 months.

Arm Title

Dabigatran/Ticagrelor

Arm Type

Experimental

Arm Description

Patiënt receive standard care, with dabigatran + ticagrelor 90mg twice daily up to 12 months.

Intervention Type

Drug

Intervention Name(s)

Dabigatran + Ticagrelor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dabigatran + clopidogrel

Intervention Description

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

Primary Outcome Measure Information:

Title

Bleeding

Description

Bleeding defined as BARC bleeding score ≥2

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Myocardial Infarction

Description

Myocardial Infarction

Time Frame

12 months

Title

Cerebrovascular accident

Description

Cerebrovascular accident, ischemic of haemorrhagic

Time Frame

12 months

Title

Systemic Embolic Complications

Description

Systemic Embolic Complications

Time Frame

12 months

Title

Death

Description

Death

Time Frame

12 months

Title

Combined endpoint of ischemic events

Description

All secondary outcomes combined into one endpoint

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Permanent, persistent or paroxysmal atrial fibrillation are eligible. PCI and successful stenting with DES for ACS (unstable angina pectoris, NSTEMI, STEMI) Written informed consent. Exclusion Criteria: Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study Glomerular filtration rate < 30 ml/min Heart valve prosthesis (mechanical or biological) Cardiogenic shock Contra-indication for Dabigatran, Ticagrelor or Clopidogrel Liver dysfunction (ALAT, ASAT, Alkaline phosphatase > 3x upper limit of normal) or liver disease (like hepatitis A, B, C) Lesion or condition with a significant risk of serious bleeding, such as; current or recent gastrointestinal ulceration; malignant neoplasms with more bleeding risk; recent brain / spinal cord injury; recent surgery on the brain, spinal cord or eyes; recent or history of intracranial haemorrhage; oesophageal varices; arteriovenous malformations; vascular aneurysms; o severe intraspinal or intracerebral vascular abnormalities. comedication with cyclosporine, itraconazole, ketoconazole (systemic) and glecaprevir / pibrentasvir, dronedarone, rifampicine, carbamazepine, St. Jan's wort or phenytoin o Comedication with tacrolimus is not recommended. Allergy to for Dabigatran, Ticagrelor or Clopidogrel Pregnancy Significant thrombocytopenia (platelet count < 50x10 9/L) Major bleeding according to BARC ≥3 within the past 6 months. Weight < 50 kg

Facility Information:

Facility Name

Zuyderland MC

City

Heerlen

State/Province

Limburg

ZIP/Postal Code

6419PC

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patty Winkler

Phone

+31 6 53368084

p.winkler@zuyderland.nl

First Name & Middle Initial & Last Name & Degree

Jasper Luijkx

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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