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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02164864
First received: June 13, 2014
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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 Dual Antithrombotic Therapy (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 ASA <= 100mg q.d. (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome (ACS)).

The study aims to show non-inferiority of both doses of DE-DAT when compared to Warfarin-TAT in efficacy and safety. Efficacy will be determined by comparing a composite death and thrombotic event rate of death, myocardial infarction, stroke and systemic embolism. In addition, comparisons will be made of the rates of clinically relevant bleeding, assessed using the modified International Society of Thrombosis and Haemostasis (ISTH) major classification.


Condition Intervention Phase
Atrial Fibrillation
Percutaneous Coronary Intervention
Drug: Dabigatran Etexilate 110mg
Drug: Warfarin 3mg
Drug: Aspirin
Drug: Dabigatran Etexilate 150mg
Drug: Clopidogrel or Ticagrelor
Drug: Warfarin 5mg
Drug: Warfarin 1mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Time to death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)) [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to first International Society of Thrombosis and Haemostasis Major Bleeding Event [ Time Frame: up to 30 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to event for individual outcome events - Undetermined cause of death [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Non-cardiovascular death [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Cardiovascular death [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - All death [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Myocardial Infarction [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Stroke [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - SE [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for individual outcome events - Stent Thrombosis [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for the composite endpoint of death + MI + stroke [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
  • Time to event for repeated revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 8520
Study Start Date: July 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran Etexilate 110mg
Patient to receive Dabigatran Etexilate 110mg BID
Drug: Dabigatran Etexilate 110mg
Active treatment
Drug: Clopidogrel or Ticagrelor
Active treatment
Experimental: Dabigatran Etexilate 150mg
Patient to receive Dabigatran Etexilate 150mg BID
Drug: Dabigatran Etexilate 150mg
Active treatment
Drug: Clopidogrel or Ticagrelor
Active treatment
Active Comparator: Warfarin
Warfarin doses to maintain INR
Drug: Warfarin 3mg
Active comparator
Drug: Aspirin
Active comparator
Drug: Clopidogrel or Ticagrelor
Active comparator
Drug: Warfarin 5mg
Active comparator
Drug: Warfarin 1mg
Active comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02164864

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, District of Columbia
1160.186.10103 Boehringer Ingelheim Investigational Site Not yet recruiting
Washington, District of Columbia, United States
United States, Florida
1160.186.10102 Boehringer Ingelheim Investigational Site Not yet recruiting
Jacksonville, Florida, United States
United States, New Jersey
1160.186.10101 Boehringer Ingelheim Investigational Site Not yet recruiting
Voorhees, New Jersey, United States
Canada, Manitoba
1160.186.15108 Boehringer Ingelheim Investigational Site Not yet recruiting
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
1160.186.15109 Boehringer Ingelheim Investigational Site Not yet recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
1160.186.15106 Boehringer Ingelheim Investigational Site Not yet recruiting
Hamilton, Ontario, Canada
1160.186.15103 Boehringer Ingelheim Investigational Site Not yet recruiting
Peterborough, Ontario, Canada
1160.186.15104 Boehringer Ingelheim Investigational Site Not yet recruiting
Sudbury, Ontario, Canada
1160.186.15105 Boehringer Ingelheim Investigational Site Not yet recruiting
Toronto, Ontario, Canada
1160.186.15102 Boehringer Ingelheim Investigational Site Not yet recruiting
Toronto, Ontario, Canada
Canada, Quebec
1160.186.15107 Boehringer Ingelheim Investigational Site Not yet recruiting
Montreal, Quebec, Canada
1160.186.15101 Boehringer Ingelheim Investigational Site Not yet recruiting
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02164864     History of Changes
Other Study ID Numbers: 1160.186, 2013-003201-26
Study First Received: June 13, 2014
Last Updated: July 9, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Austrian Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China:
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Agency for Medicinal Product and Medical Devices
Czech Republic: State Institute for Drug Control
Denmark: The Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India:
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: AIFA (Italian Medicine Agency)
Japan: Ministry of Health, Labor and Welfare
Korea: Ministry of Food and Drug Safety
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Spanish Agency of Medicines and Medical Devices
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Ticlopidine
Clopidogrel
Warfarin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014