Anticoagulant Treatments and Percutaneous Coronary Angioplasty

Study Overview
=================
Brief 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, …).

Official Title
-----------------
Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: clopidogrel + aspirin
* Drug: heparin + clopidogrel + aspirin
* Drug: enoxaparin + clopidogrel + aspirin
* Drug: bivalirudin + clopidogrel + aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable angina pectoris or silent ischaemia Exclusion Criteria: instable angina or ACS (Acute Coronary Syndrome)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>group without anticoagulant therapy | Drug: clopidogrel + aspirin<br> <br> * Other names: Plavix Kardégic;|
| Active Comparator: 2<br>group with heparin | Drug: heparin + clopidogrel + aspirin<br> <br> * Other names: héparine Choay Plavix Kardégic;|
| Active Comparator: 3<br>group with enoxaparin | Drug: enoxaparin + clopidogrel + aspirin<br> <br> * Other names: Lovenox Plavix Kardégic;|
| Active Comparator: 4<br>group with bivalirudin | Drug: bivalirudin + clopidogrel + aspirin<br> <br> * Other names: Angiox Plavix Kardégic;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischaemic events via troponin Ic measurements during 24 hours post procedure |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haemorrhagic events : clinical and biological evaluation |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ptca, antiaggregant therapy, anticoagulant therapy