Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous C… (NCT00508924) | Clinical Trial Compass
CompletedPhase 2
Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)
Belgium, Germany140 participantsStarted 2005-08
Plain-language summary
This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the information on dose-response of argatroban in pharmacodynamic markers and to assess the anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in combination with dual antiplatelet therapy.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female (women of child bearing potential must have a negative pregnancy test prior to entry into the study)
* Aged over 18 years
* 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
* Signed written informed consent
Exclusion Criteria:
* 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.
* Known cirrhosis, hepatitis, clinically significant hepatic disorder, or history of hepatic disorder. Hepatic disorder is defined as having levels of liver function tests (bilirubin, Aspartate Aminotransferase (Serum Glutamate Oxaloacetate Transaminase)(AST (SGOT)), Alanine Aminotransferase (Serum Glutamate Pyruvate Transaminase)(ALT (SGPT)) greater than 3.0 times above the upper limit of the normal range of local laboratory.
* Patients not currently taking aspirin
* Renal insufficiency, defined as serum creatinine greater than 2.0 mg/dL (greater than 177mmol/L)
* Platelets less than 125,000/ml
* If already taking any form of heparin prior to study enrolment, Activated Partial Thromboplastin Time(aPTT) equal or greater than 35 sec or ACT g…
What they're measuring
1
Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.
Timeframe: 5 - 10 min after initial bolus
2
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.