Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
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Purpose
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.
| Condition | Intervention | Phase |
|---|---|---|
|
Thromboembolism |
Drug: dabigatran etexilate 150 mg Drug: warfarin (INR 2-3) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication. |
- Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE [ Time Frame: From randomisation to end of post treatment period (day 224) ] [ Designated as safety issue: No ]All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants With Recurrent Symptomatic VTE and All Deaths [ Time Frame: From randomisation to end of post treatment period (day 224) ] [ Designated as safety issue: No ]
VTE or any death which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants With Recurrent Symptomatic DVT [ Time Frame: From randomisation to end of post treatment period (day 224) ] [ Designated as safety issue: No ]
Symptomatic DVT which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants With Recurrent Symptomatic Non-fatal PE [ Time Frame: From randomisation to end of post treatment period (day 224) ] [ Designated as safety issue: No ]
Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants Who Died Due to VTE [ Time Frame: From randomisation to end of post treatment period (day 224) ] [ Designated as safety issue: No ]
VTE - related deaths which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants Who Died (Any Cause) [ Time Frame: From randomisation to end of post treatment period (day 224) ] [ Designated as safety issue: No ]Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants With Major Bleeding Events [ Time Frame: From first intake of study drug to last intake of study drug + 6 days ] [ Designated as safety issue: Yes ]
Major Bleeding Events defined as per the recommendations of the International Society on Thrombosis and Haemostasis. A bleeding event was categorised as an MBE (adjudicated by the independent central assessment committee) if it fulfilled at least one of the following criteria:
- Fatal bleeding,
- Symptomatic bleeding in a critical area or organ,
- Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.
| Enrollment: | 2564 |
| Study Start Date: | February 2006 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: dabigatran etexilate 150 mg
twice daily
|
Drug: dabigatran etexilate 150 mg
twice daily
|
|
Active Comparator: warfarin (INR 2-3)
prn to maintain INR (2-3)
|
Drug: warfarin (INR 2-3)
prn to maintain INR (2-3)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
- Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
- Male or female, being 18 years of age or older
- Written informed consent for study participation
Exclusion criteria
- Overt symptoms of VTE for longer than 2 weeks prior to enrolment
- PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
- Actual or anticipated use of vena cava filter
- Contraindications to anticoagulant therapy
- Patients who in the investigators opinion should not be treated with warfarin
- Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
- Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
- Known anaemia
- Need of anticoagulant treatment for disorders other than VTE
- Recent unstable cardiovascular disease
- Elevated AST or ALT > 2x ULN
- Liver disease expected to have any potential impact on survival
- Patients who have developed transaminase elevations upon exposure to ximelagatran
- Severe renal impairment
- Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
- Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
- Patients considered unsuitable for inclusion by the investigator
Contacts and Locations
Show 250 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00291330 History of Changes |
| Other Study ID Numbers: | 1160.53, 2005-001999-12 |
| Study First Received: | February 13, 2006 |
| Results First Received: | November 18, 2010 |
| Last Updated: | June 22, 2012 |
| Health Authority: | Argentina: A.N.M.A.T. (National Administration of Medications, Food and Medical Technology) Australia: Responsilble Ethics Committee Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicines and Health Products Brazil: National Health Surveillance Agency Canada: Health Canada, Therapeutic Products Directorate Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10 Denmark: The Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Great Britain: MHRA Greece: National Organization for Medicines (EOF) National Ethics Committee Hungary: National Institute of Pharmacy, H-1051 Budapest India: Drug Control General of India Israel: Clinical trials unit, pharmaceutical division, ministry of health 29 Rivka street Jerusalem Italy: Comitato Etico Aziende Sanitarie Umbria - ELLERA DI CORCIANO (PG) Mexico: Federal Commission for Protection Against Health Risks Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) New Zealand: Multicentre Ethics Committee/Medsafe Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Portugal: INFARMED - National Authority of Medicines and Health Products, IP Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 South Africa: Medicines Control Council Spain: Spanish Agency for Medicines and Health Products Sweden: The National Board of Health and Welfare Turkey: Ministry of Health Central Ethics Committee Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Thrombosis Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013