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
Conditions
Interventions
Trade Name: Argatra Multidose
Product Name: Not applicable (since trade name exist)
Product Code: Not applicable (since trade name exist)
Pharmaceutical Form: Concentrate for solution for infusio
Sponsors
Mitsubishi Tanabe Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine change of QTc interval during intravenous argatroban infusion in patients undergoing PCI. To observe whether argatroban has a pharmacological effect on cardiac repolarization, it will be investigated, if a mean QTc prolongation of more than 10 ms will occur between ECG-2 (ECG immediately after cardiac intervention when patient is fully anticoagulated with argatroban) and ECG-1 (baseline ECG).;Secondary Objective: - Determination of the QTc interval after sufficient wash-out period by ECG-3 which needs to be performed > 8 but = 28 hours after termination of prolonged argatroban infusion. - Investigation of dependence of QTc interval on gender and applied doses. - Determination of coagulation status during argatroban therapy. - Assessment of safety-related events within the scope of anticoagulation with argatroban, for example bleeding events or thomboembolic events. ;Primary end point(s): The primary endpoint of this study is the mean difference in QTc interval between ECG-2 and ECG-1.;Timepoint(s) of evaluation of this end point: QT interval of ECG-1 will be measured at screening visit which takes place up to 72 to 12h before treatment visit. Evaluation of QT interval at ECG-2 is intended immediately after PCI at the end of treatment visit. Thus, the evaluation of primary endpoint is possible as soon as QT data and heart rate of ECG-2 are available. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean difference in QTc interval between ECG-3 (ECG > 8 but = 28 hours after termination of prolonged argatroban infusion) and ECG-1. Proportion of patients with a prolongation of QTc interval to > 500 ms at ECG-2. Proportion of patients with a prolongation of QTc interval to > 500 ms at ECG-3. Proportion of patients with a prolongation of QTc interval of > 60 ms at ECG-2 compared to ECG-1. Proportion of patients with a prolongation of QTc interval of > 60 ms at ECG-3 compared to ECG-1. Incidence of haemorrhagic events according to the definition of CABG-related bleeding. Incidence of adverse events. ;Timepoint(s) of evaluation of this end point: The endpoints related to proportion of patients with QT interval prolongation at ECG-2 can be evaluated after ECG-2 which is at the end of the treatment visit. Endpoints related to proportion of patients with prolonged QT interval at ECG-3 can be evaluated directly after ECG-3 as soon as the measured QT interval is available. ECG-3 is planned > 8 but = 28 hours after termination of prolonged argatroban infusion. The incidence of haemorrhagic events including adverse events will be assessed from study start (date of treatment visit) until 28 days after study termination at the latest. Thus, this endpoint can be evaluated as soon as the AE follow-up phase is finished. | — |
Countries
Germany
Contacts
Public ContactGeneral Information
Mitsubishi Tanabe Pharma Europe Ltd
Outcome results
None listed