Follow on study from RE-ALIGN

Evaluation of the long term safety of the use of dabigatran etexilate in patients with a bileaflet mechanical heart valve - RE-ALIGN-EX

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002285-21-CZ

Enrollment

405

Registered

2011-09-06

Start date

2011-12-20

Completion date

Unknown

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulation following mechanical heart valve surgery MedDRA version: 14.0 Level: PT Classification code 10053468 Term: Anticoagulant therapy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Pradaxa 110 mg hard capsules Product Name: dabigatran etexilate Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: DABIGATRAN ETEXILATE Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Completed study 1160.113 per protocol 2. Continuing need for anticoagulation 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 265 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140

Exclusion criteria

Exclusion criteria: 1. uncontrolled hypertension 2. severe renal impairment 3. active liver disease 4. increased risk of bleeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to obtain long term safety data regarding the use of dabigatran etexilate in patients having received a mechanical bileaflet heart valve.;Secondary Objective: no formal secondary objectives;Primary end point(s): 1: There are no primary or secondary efficacy or safety variables for this study ;Timepoint(s) of evaluation of this end point: clinical safety and efficacy endpoints will be studied in an exploratory manner only	—

Measure

Time frame

Main Objective: The primary objective of this trial is to obtain long term safety data regarding the use of dabigatran etexilate in patients having received a mechanical bileaflet heart valve.;Secondary Objective: no formal secondary objectives;Primary end point(s): 1: There are no primary or secondary efficacy or safety variables for this study ;Timepoint(s) of evaluation of this end point: clinical safety and efficacy endpoints will be studied in an exploratory manner only

—

Secondary

Measure	Time frame
Secondary end point(s): There are no primary or secondary efficacy or safety variables for this study ;Timepoint(s) of evaluation of this end point: clinical safety and efficacy endpoints will be studied in an exploratory manner only	—

Countries

Belgium, Canada, Czech Republic, Denmark, France, Germany, Netherlands, Norway, Poland, Sweden, United States

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co KG

clintriage.rdg@boehringer-ingelheim.com+18002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026