Investigation of the influence of the antithrombic agent argatroban on the electric conduction in the heart.

Phase 1

• Conditions: Patients without diagnosed HIT II but with a coronary heart disease and with a diagnosed stable or unstable angina are planned for a percutaneous coronary intervention (PCI) according to clinical routine. Patients undergoing an elective PCI require an antithromotic therapy. In this trial argatroban will be used for parenteral antithrombotic therapy of adult patients undergoing a routine PCI. The influence of argatroban on QT interval will be investigated during the PCI-related treatment.; MedDRA version: 20.0Level: PTClassification code 10003211Term: Arteriosclerosis coronary arterySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003521-42-DE
• Lead Sponsor: Mitsubishi Tanabe Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-25
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The patient is at least 18 years of age; Patient is willing to give written informed consent and willingness to participate and to comply with the requirements of the study protocol; Patient with diagnosed stable or unstable angina (troponin negative); Patient requires elective percutaneous coronary angioplasty or stent insertion with an approved device in one or more de novo-treated or re-stenotic lesions in native vessels, Baseline ECG without changes that impair assessment of QTc interval, Patient is on adequate platelet inhibition therapy after receiving a loading dose with ASA and clopidogrel before start of intervention.
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient is pregnant or nursing, participation in another clinical trials within last 3 months prior to study start; any condition contraindicates the use of argatroban; marked baseline prolongation of QTc interval at baseline ECG; known intraventricular conduction disturbance; use of concomitant medications that interfere with the QTc interval; intake of digitalis within the last 2 weeks before study start; acute myocardial infarction or troponin-positive unstable angina; known hepatic disorder and renal insufficiency; intake of heparin and aPTT = 35 s at screening; intake of direct oral anticoagulants; intake of anticoagulants of vitamin K antagonists and INR >1.2 at screening.

Study & Design

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