Official Title: “Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

- 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, …).

Intervention(s) in this Clinical Trial

• Drug: clopidogrel + aspirin
• Drug: heparin + clopidogrel + aspirin
• Drug: enoxaparin + clopidogrel + aspirin
• Drug: bivalirudin + clopidogrel + aspirin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • group without anticoagulant therapy
• Active Comparator: 2
  • group with heparin
• Active Comparator: 3
  • group with enoxaparin
• Active Comparator: 4
  • group with bivalirudin

Primary Measures

• ischaemic events via troponin Ic measurements during 24 hours post procedure
  • Time Frame: 24 hours
    Safety Issue?: No

Secondary Measures

• haemorrhagic events : clinical and biological evaluation
  • Time Frame: 24 hours
    Safety Issue?: Yes

Inclusion Criteria:

• stable angina pectoris or silent ischaemia

Exclusion Criteria:

• instable angina or ACS (Acute Coronary Syndrome)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Centre Hospitalier de PAU

Overall Clinical Trial Officials and Contacts

Nicolas DELARCHE, MD Principal Investigator CH de Pau  

Overall Contact: Nicolas DELARCHE, MD 55-992-4883 n.delarche@wanadoo.fr

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669149

Study ID Number: CHPAU 2007/01

ClinicalTrials.gov Identifier: NCT00669149

Health Authority: France: Afssaps - French Health Products Safety Agency