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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688723
• Other study ID #: METCZ20200196
• Status: Recruiting
• Phase: Phase 4
• Start date: December 23, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: December 2020
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dabigatran + Ticagrelor
Patiënt interventional treatment, with dabigatran + ticagrelor (Brilique) 90mg twice daily up to 12 months.
• Dabigatran + clopidogrel
Patiënt interventional treatment, with dabigatran + clopidogrel (plavix) 75mg once daily up to 12 months.

Locations

Country	Name	City	State
Netherlands	Zuyderland MC	Heerlen	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum	Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding	Bleeding defined as BARC bleeding score =2	12 months
Secondary	Myocardial Infarction	Myocardial Infarction	12 months
Secondary	Cerebrovascular accident	Cerebrovascular accident, ischemic of haemorrhagic	12 months
Secondary	Systemic Embolic Complications	Systemic Embolic Complications	12 months
Secondary	Death	Death	12 months
Secondary	Combined endpoint of ischemic events	All secondary outcomes combined into one endpoint	12 months