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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02164864
• Date of registration: 13/06/2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
• Scientific title: A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting
• Date of first enrolment: July 22, 2014
• Target sample size: 2725
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02164864
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Czechia, Denmark, El Salvador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, Slovenia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Percutaneous Coronary Intervention

Atrial Fibrillation

Intervention(s)

Drug: Dabigatran Etexilate 150mg

Drug: Warfarin 5mg

Drug: Aspirin

Drug: Dabigatran Etexilate 110mg

Drug: Warfarin 1mg

Drug: Clopidogrel or Ticagrelor

Drug: Warfarin 3mg

Primary Outcome(s)

Time to First Adjudicated ISTH MBE or CRNMBE [Time Frame: up to 30 months]

Secondary Outcome(s)

Time to Adjudicated CV [Time Frame: up to 30 months]

Time to Adjudicated Non-CV [Time Frame: up to 30 months]

Time to Adjudicated Undetermined Cause of Death [Time Frame: up to 30 months]

Time to Composite Endpoint of Death + MI + Stroke [Time Frame: up to 30 months]

Time to First Adjudicated SE [Time Frame: up to 30 months]

Time to Composite Endpoint of Death or First Thrombotic Event [Time Frame: up to 30 months]

Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG [Time Frame: up to 30 months]

Time to Adjudicated All Cause Death [Time Frame: up to 30 months]

Time to First Adjudicated Unplanned Revascularisation by PCI/CABG [Time Frame: up to 30 months]

Time to First Adjudicated Stroke [Time Frame: up to 30 months]

Time to First Adjudicated MI [Time Frame: up to 30 months]

Time to First Adjudicated ST [Time Frame: up to 30 months]

Secondary ID(s)

2013-003201-26

1160.186

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02164864