Anticoagulant Treatments and Percutaneous Coronary Angioplasty

Phase 4

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Drug: heparin + clopidogrel + aspirin; Drug: bivalirudin + clopidogrel + aspirin; Drug: clopidogrel + aspirin; Drug: enoxaparin + clopidogrel + aspirin

• Registration Number: NCT00669149
• Lead Sponsor: Centre Hospitalier de PAU

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, ...).

Study Timeline

• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Study Start: 2008-06
• Primary Completion: 2013-08-03
• Study Completion: 2013-08-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• stable angina pectoris or silent ischaemia

Exclusion Criteria

• instable angina or ACS (Acute Coronary Syndrome)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	heparin + clopidogrel + aspirin	group with heparin
4	bivalirudin + clopidogrel + aspirin	group with bivalirudin
1	clopidogrel + aspirin	group without anticoagulant therapy
3	enoxaparin + clopidogrel + aspirin	group with enoxaparin

Primary Outcome Measures

Name	Time	Method
ischaemic events via troponin Ic measurements during 24 hours post procedure	24 hours

Secondary Outcome Measures

Name	Time	Method
haemorrhagic events : clinical and biological evaluation	24 hours

Trial Locations

Locations (1)

Centre Hospitalier de Pau; 🇫🇷 PAU, Pyrénées-Atlantiques, France