Stable coronary artery disease (CAD) or unstable angina (troponin negative, i.e. within the normal range for the study site) with low to moderate anatomic risk and a requirement for 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. MedDRA version: 7.1 Level: LLT Classification code 10011078
Conditions
Interventions
Product Name: Argatroban
Product Code: MCI-9038
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Argatroban
CAS Number: 74863-84-6
Current Sponsor code: MCI-9038
Other d
Sponsors
Mitsubishi Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this trial, patients must meet all of the following criteria: 1. Male or female (women of child bearing potential must have a negative pregnancy test prior to entry into the study) 2. Aged over 18 years 3. Diagnosis of stable coronary artery disease (CAD) or unstable angina (troponin negative, i.e. within the normal range for the study site) with low to moderate anatomic risk and a requirement for 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 4. Signed written 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
Exclusion criteria: Patients meeting any of the following criteria will be excluded from participation in the study: 1. Any condition which, in the investigator’s opinion, contraindicates the use of argatroban, heparin or clopidogrel or endangers the patient if he/she participated in this study. 2. Known cirrhosis, hepatitis, clinically significant hepatic disorder, or history of hepatic disorder. Hepatic disorder is defined as having levels of liver function tests (bilirubin, AST (SGOT), ALT (SGPT) greater than 3.0 times above the upper limit of the normal range of local laboratory. 3. Patients not currently taking aspirin. 4. Renal insufficiency, defined as serum creatinine greater than 2.0 mg/dL (greater than 177micromol/L). 5. Platelets less than 125,000/microl. 6. If already taking any form of heparin prior to study enrolment, aPTT equal or greater than 35 sec or ACT greater than 160 sec. 7. Use of low molecular heparin (LMWH) during 12 h prior to PCI. 8. If taking oral anticoagulant medication prior to study enrolment, INR greater than 1.2. 9. Q wave MI with cardiogenic shock or thrombolytic therapy within 72 h of study dosing. 10. Use of GPIIb/IIIa inhibitors within prior 3 weeks. 11. Documented coagulation disorder or bleeding diathesis. 12. Lumbar puncture within the past 2 weeks. 13. History of previous cerebral aneurysm, haemorrhagic stroke, or thrombotic stroke within the past 6 months. 14. Active, uncontrolled peptic ulcer disease or any gastrointestinal bleeding or genitourinary bleeding within 3 months prior to study enrolment. 15. Major surgery, serious trauma, puncture of non-compressible vessel, or biopsy of parenchymal organ within prior 2 months. 16. Planned staged procedure, planned rotational atherectomy, directional coronary atherectomy, brachytherapy, or thrombectomy catheters within 30 days after PCI. 17. Planned surgical intervention other than study procedure within next 7 days. 18. Presence of greater than 50% stenosis of unprotected left main coronary artery. 19. Severe peripheral vascular disease, precluding femoral access. 20. History of vasculitis. 21. Uncontrolled hypertension defined as greater than 180/110 mmHg. 22. Pregnancy (exclusion by routine urine test). 23. Lactating woman. 24. Woman of children bearing age who are or were not using a highly effective method of birth-control; this is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUD's, sexual abstinence or vasectomised partner. 25. Participation in other clinical trials of investigational products within 3 months prior to study enrolment. 26. Terminally ill patients with a life expectancy of < 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain information about the safety and effects on various pharmacodynamic markers, of three doses of argatroban when used in combination with clopidogrel and aspirin.;Secondary Objective: To assess the results of three doses of argatroban when used in combination with clopidogrel and aspirin and UFH when used in combination with clopidogrel and aspirin on clinical outcomes (composite and each of all-cause and cardiovascular death, myocardial infarction, urgent revascularisation at day 30, and major and minor bleeding episodes during hospital stay), adequacy of anticoagulation, various pharmacodynamic markers, pharmacokinetics and the incidence of heparin antibodies.;Primary end point(s): A. Triple and quadruple composite and each of all-cause (and cardiovascular) death, myocardial infarction (MI), and urgent revascularisation at Day 30, and major bleeding events during hospital stay B. Minor Bleeding Events during Hospital Stay C. ACT value after the first dosing of study treatment (5 - 10 mins after completion of bolus) D. Effects on pharmacodynamic markers, including some or all of: aPTT and activated clotting time (ACT), thrombin-antithrombin complex (TAT), D-dimer, ecarin test (ECAT), endogenous thrombin potential (ETP), prothrombinase-induced clotting time (PiCT), troponin (Tn), CD40L, C-Reactive Protein (CRP), Interleukin-6 (IL-6), tumour necrosis factor alpha (TNF-alpha), tissue factor (TF), tissue factor pathway inhibitor (TFPI), von Willebrand factor (vWF), low concentration ADP-induced platelet aggregation and monocyte chemotactic protein-1 (MCP-1) Measurements for D-Dimer, TAT, CD40L and CRP will be measured at baseline and 24 h, other measurements will be taken at baseline (prior to argatroban or UFH dosing), 5 - 10 mins and 30 mins after completion of bolus, at end of PCI procedure, 2 h after end of PCI procedure, and at 24 h after the end of the PCI procedure/hospital discharge E. Number of additional boluses needed to reach | — |
Countries
Germany
Outcome results
None listed