Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation; Percutaneous Coronary Intervention

Treatments: Drug: Warfarin 5mg; Drug: Dabigatran Etexilate 110mg; Drug: Dabigatran Etexilate 150mg; Drug: Clopidogrel or Ticagrelor; Drug: Warfarin 1mg; Drug: Aspirin; Drug: Warfarin 3mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02164864

2013-003201-26 (EudraCT Number)

1160.186

Details and patient eligibility

About

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.

Enrollment: 2,725 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged >=18 years
• Patients with Non Valvular Atrial Fibrillation
• Patient presenting with:

An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)

• The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.

Exclusion criteria

• Patients with a mechanical or biological heart valve prosthesis
• Cardiogenic shock during current hospitalisation
• Stroke within 1 month prior to screening visit
• Patients who have had major surgery within the month prior to screening
• Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
• Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
• Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening
• Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
• Active liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,725 participants in 3 patient groups

Dabigatran Etexilate 110mg

Experimental group

Description:

Patient to receive Dabigatran Etexilate 110mg twice a day (BID)

Treatment:

Drug: Clopidogrel or Ticagrelor

Drug: Clopidogrel or Ticagrelor

Drug: Dabigatran Etexilate 110mg

Drug: Clopidogrel or Ticagrelor

Dabigatran Etexilate 150mg

Experimental group

Description:

Patient to receive Dabigatran Etexilate 150mg twice a day (BID)

Treatment:

Drug: Clopidogrel or Ticagrelor

Drug: Clopidogrel or Ticagrelor

Drug: Clopidogrel or Ticagrelor

Drug: Dabigatran Etexilate 150mg

Warfarin

Active Comparator group

Description:

Warfarin doses to maintain INR

Treatment:

Drug: Clopidogrel or Ticagrelor

Drug: Aspirin

Drug: Clopidogrel or Ticagrelor

Drug: Warfarin 5mg

Drug: Clopidogrel or Ticagrelor

Drug: Warfarin 3mg

Drug: Warfarin 1mg