Follow on Study From RE-ALIGN

Phase 2TerminatedNCT01505881

Boehringer Ingelheim158 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

158

Conditions

Thromboembolism Heart Valve Prosthesis

Interventions

dabigatran etexilate low doseDRUG

active treatment (low)

warfarin 5mgDRUG

comparator warfarin

dabigatran etexilate intermediate doseDRUG

active treatment (medium)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Completed study 1160.113 per protocol 2. Continuing need for anticoagulation Exclusion criteria: 1. uncontrolled hypertension 2. severe renal impairment 3. active liver disease 4. increased risk of bleeding

Locations (30)

Outcomes

Primary Outcomes

Percentage of Patients With Any Adverse Event (AE)

Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.

Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Secondary Outcomes

Percentage of Patients With AEs Leading to Discontinuation of Trial Drug

Percentage of patients with Adverse Events leading to discontinuation of trial drug. Prespecified clinical outcome events were not recorded as Adverse Events.

Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Percentage of Patients With Serious AEs

Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.

Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.

Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis

Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Data from ClinicalTrials.gov

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1160.138.32003 Boehringer Ingelheim Investigational Site

Brussels, 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, Czechia

1160.138.42003 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

...and 20 more locations