Randomized, Open-label study of Dabigatran Etexilate, a Novel, oral, Direct Thrombin-inhibitor in clinical development, in Elective Percutaneous Coronary Intervention. (D-Fine) - D-Fine

Phase 1

Active, not recruiting

• Conditions: Acute Coronary Syndrome; MedDRA version: 9.1Level: PTClassification code 10051592Term: Acute coronary syndrome

• Registration Number: EUCTR2007-007536-25-NL
• Lead Sponsor: Boehringer Ingelheim b.v.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-02
• Study Completion: 2010-08-07
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients are eligible for the study if they are:
1.between 18 and 85 years of age, both included
2.due to undergo an elective (non urgent) PCI on one or multiple lesions in the native coronary vessel(s) via a femoral approach
3.if they provide informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients are excluded from this study if:
1.Not a candidate for PCI. Lesion specific conditions:
-Left main disease
-Chronic Total Occlusions
-Bifurcation lesions, or hemodynamic sidebranch
-Three vessel disease requiring treatment of more than 2 lesions (no staging is allowed)
-PCI for restenosis.
2.New York Heart Association class III or IV congestive heart failure.
3.Hemodynamic instability.
4.Severe hypertension not adequately controlled by antihypertensive therapy at the screening visit (Blood Pressure > 180/110mmHg).
5.Significant mitral or aortic valves disease.
6.Increased bleeding risk:
-Ischemic stroke within the last year or history of any previous hemorrhagic stroke, or intracranial aneurysm
-Recent (< 1 month) trauma or major surgery (including bypass surgery) in the last 3 months
-Symptomatic or endoscopically documented ulcer disease in the previous 30 days
-Active or recent (< 3 months) major, minor TIMI definition-bleeding
-Impaired hemostasis: Thrombocytopenia ( platelet count <100*109) or active bleeding disorder
-Anticoagulant (heparin, coumarin) use; international normalized ratio >1.5
-Use of oral non steroidal inflammatory drugs (NSAID) within 12 hrs prior to PCI
-Past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand’s disease or hemophillia; acquired bleeding disorders; and unexplained clinically significant bleeding disorders)
7.Thrombolytic therapy within 24 hours preceding randomization
8.Severe renal impairment (e.g. known creatinine clearance < 30 mL/min (GFR -assessed by the Modification of Diet in Renal Disease (MDRD) study equation) or clinical markers of severe renal impairment) [R02-2429] [R02-2529]
9.Known liver disease (e.g. known high concentrations of liver enzymes (more than twice the ULN))
10.Pre-menopausal (last menstruation < 1 year prior to screening) sexually active women who: are pregnant or nursing or are not surgically sterile or are of child bearing potential and not practicing an acceptable method of birth control, (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, double barrier or vasectomised partner)
11.A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (Visit 1)
12.Treatment with other investigational drugs or devices within 30 days before enrolment or planned use of investigational drugs or devices during the study
13.Use of quinidine
14.Known allergy, hypersensitivity or contraindication to clopidogrel, aspirin.
15.Inability to give informed consent or high likelihood of being unavailable for follow-up
16.Inability or unwillingness to perform 7-14 day follow up
17.Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether two doses of dabigatran etexilate (110 mg b.i.d., 150 mg b.i.d.) as compared to UFH, both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective PCI.;Secondary Objective: - To assess the coagulation profile of two different doses of dabigatran etexilate in addition to a standard dual antiplatelet regimen in the setting of elective PCI.<br>- To investigate the safety of dabigatran etexilate plus dual antiplatelet therapy, particularly with respect to bleeding complications.<br>;Primary end point(s): Anticoagulant effect will be determined based on the number of patients who need rescue anticoagulant and/or have clinical signs of catheter related thrombosis during the PCI procedure (until removal of the guiding catheter and the patient has left the catheterization suite).