Follow on Study From RE-ALIGN

Phase 2

Terminated

• Conditions: Heart Valve Prosthesis; Thromboembolism
• Interventions: Drug: warfarin 5mg; Drug: dabigatran etexilate low dose; Drug: dabigatran etexilate intermediate dose; Drug: warfarin 1mg; Drug: warfarin 3mg; Drug: dabigatran etexilate high dose

• Registration Number: NCT01505881
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-09
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-06-06
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-10
• Last Update Submitted: 2014-07-10
• Results First Posted: 2014-07-11
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
warfarin	warfarin 5mg	warfarin doses to maintain INR levels
warfarin	warfarin 3mg	warfarin doses to maintain INR levels
Dabigatran etexilate	dabigatran etexilate intermediate dose	Patient dose determined by dose allocated in 1160.113 and CrCl levels
warfarin	warfarin 1mg	warfarin doses to maintain INR levels
Dabigatran etexilate	dabigatran etexilate high dose	Patient dose determined by dose allocated in 1160.113 and CrCl levels
Dabigatran etexilate	dabigatran etexilate low dose	Patient dose determined by dose allocated in 1160.113 and CrCl levels

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Any Adverse Event (AE)	From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)	Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Serious AEs	From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)	Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.	From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)	Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis
Percentage of Patients With AEs Leading to Discontinuation of Trial Drug	From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)	Percentage of patients with Adverse Events leading to discontinuation of trial drug.; Prespecified clinical outcome events were not recorded as Adverse Events.

Trial Locations

Locations (30)

1160.138.32003 Boehringer Ingelheim Investigational Site; 🇧🇪 Bruxelles, Belgium

1160.138.32002 Boehringer Ingelheim Investigational Site; 🇧🇪 Genk, Belgium

1160.138.32001 Boehringer Ingelheim Investigational Site; 🇧🇪 Leuven, Belgium

1160.138.11001 Boehringer Ingelheim Investigational Site; 🇨🇦 Saint John, New Brunswick, Canada

1160.138.11009 Boehringer Ingelheim Investigational Site; 🇨🇦 Hamilton, Ontario, Canada

1160.138.11011 Boehringer Ingelheim Investigational Site; 🇨🇦 London, Ontario, Canada

1160.138.11012 Boehringer Ingelheim Investigational Site; 🇨🇦 Newmarket, Ontario, Canada

1160.138.11007 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

1160.138.42002 Boehringer Ingelheim Investigational Site; 🇨🇿 Brno, Czech Republic

1160.138.42003 Boehringer Ingelheim Investigational Site; 🇨🇿 Olomouc, Czech Republic

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