NCT00669149

Anticoagulant Treatments and Percutaneous Coronary Angioplasty

Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Centre Hospitalier de PAU · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether adjunction of intravenous anticoagulant therapy (enoxaparin, HNF, bivalirudin) to antiaggregation with clopidogrel and aspirin improves in-hospital results of percutaneous transluminal coronary angioplasty (ptca) in selected patients.

Detailed description

* Background : We don't know if using IV anticoagulant therapy is necessary for percutaneous coronary angioplasty in stable patients. * Purpose : to compare efficacy and security of use or not of different anticoagulant treatments during percutaneous coronary angioplasty in patients with double antiaggregant therapy. * Abstract : In stable patients pretreated with double antiaggregant therapy use of IV anticoagulants has not been yet evaluated during angioplasty. In this prospective randomized trial we want to compare in such patients the efficacy and security of the administration of IV heparin, IV enoxaparin, IV bivalirudin and no use of anticoagulant during coronary angioplasty. We will evaluate in each group ischaemic events (clinic, ECG and biology) and haemorrhagic events (clinic, biology) with a one month follow up. * Primary outcome: ischaemic events via troponin Ic measurements during 24 hours post procedure. * Secondary outcomes: haemorrhagic events : clinical and biological evaluation (Hb, Ht, TIMI score) * Study design : monocentric randomized clinical trial type therapeutic equivalence phase IV. * Interventions : In patients prepared with therapeutic association (aspirin clopidogrel) comparison between use or no of anticoagulant (IV heparin, IV enoxaparin or IV bivalirudin). * Number of subjects : 120 per group (total of 480). * Statistical analysis : multivariate analysis with logistic regression models : each end point (troponin Ic increase, haemoglobin decrease, …) will be explicated with treatment group and other covariates (sex, age, creatinine, …).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	clopidogrel + aspirin
DRUG	heparin + clopidogrel + aspirin
DRUG	enoxaparin + clopidogrel + aspirin
DRUG	bivalirudin + clopidogrel + aspirin

Timeline

• Start date: 2008-06-01
• Primary completion: 2013-08-03
• Completion: 2013-08-03
• First posted: 2008-04-29
• Last updated: 2019-05-17

Locations

1 site across 1 country: France