Evaluation of Dual Therapy with Dabigatran vs. Triple Therapy with Warfarin in Patients with AF that undergo a PCI with Stenting

• Register: EUCTR
• Last refreshed on: 3 July 2017
• Main ID: EUCTR2013-003201-26-ES
• Date of registration: 04/07/2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim España, S.A.
• Public title: Evaluation of Dual Therapy with Dabigatran vs. Triple Therapy with Warfarin in Patients with AF that undergo a PCI with Stenting
• 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 - RE-DUAL PCI
• Date of first enrolment: 06/08/2014
• Target sample size: 10500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003201-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: QPRE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co.KG

• Name: QPRE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co.KG

Key inclusion & exclusion criteria

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

An ACS (STEMI, NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7220

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 CrCl calculated by Cockcroft-Gault equation) <30mL/min at screening
- Active liver disease


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting
MedDRA version: 17.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 17.0 Level: PT Classification code 10065608 Term: Percutaneous coronary intervention System Organ Class: 10042613 - Surgical and medical procedures

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Trade Name: Pradaxa
Product Name: dabigatran etexilate, 110 mg
Product Code: BIBR 1048 MS
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DABIGATRAN ETEXILATE MESILATE
Current Sponsor code: BIBR 1048 MS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 110-

Trade Name: Pradaxa
Product Name: dabigatran etexilate, 150 mg
Product Code: BIBR 1048 MS
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DABIGATRAN ETEXILATE MESILATE
Current Sponsor code: BIBR 1048 MS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Warfarin 1mg Tablets
Product Name: Warfarin
Pharmaceutical Form: Tablet
INN or Proposed INN: warfarin
Other descriptive name: WARFARIN SODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: Warfarin 3mg Tablets
Product Name: Warfarin
Pharmaceutical Form: Tablet
INN or Proposed INN: warfarin
Other descriptive name: WARFARIN SODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Trade Name: Warfarin 5 mg Tablets
Product Name: Warfarin
Pharmaceutical Form: Tablet
INN or Proposed INN: warfarin
Other descriptive name: WARFARIN SODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: To compare a dual antithrombotic treatment regimen of 110mg dabigatran etexilate twice a day (b.i.d.) plus clopidogrel or ticagrelor and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor with triple antithrombotic therapy combination of warfarin plus clopidogrel or ticagrelor plus Aspirin <= 100mg once a day (q.d.) in patients with Atrial Fibrillation (AF) that undergo a Percutaneous Coronary Intervention (PCI) with stenting.

Timepoint(s) of evaluation of this end point: 1: up to 30 months

2: up to 30 months

Secondary Objective: Not applicable

Primary end point(s): 1: Time to death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE))


2: Time to first International Society of Thrombosis and Haemostasis Major Bleeding Event

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1: up to 30 months

2: up to 30 months

3: up to 30 months

4: up to 30 months

5: up to 30 months

6: up to 30 months

7: up to 30 months

8: up to 30 months

9: up to 30 months

10: up to 30 months

Secondary end point(s): 1: Time to event for individual outcome events
- All death


2: Time to event for individual outcome events
- Myocardial Infarction


3: Time to event for individual outcome events
- Stroke


4: Time to event for individual outcome events
- SE

5: Time to event for individual outcome events
- Stent Thrombosis

6: Time to event for the composite endpoint of death + MI + stroke

7: Time to event for repeated revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft

8: Time to event for individual outcome events
- Cardiovascular death

9: Time to event for individual outcome events
- Non-cardiovascular death

10: Time to event for individual outcome events
- Undetermined cause of death

Secondary ID(s)

2013-003201-26-SE

1160.186

Source(s) of Monetary Support

Boehringer Ingelheim España, S.A.