Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: clopidogrel + aspirin; Drug: heparin + clopidogrel + aspirin; Drug: enoxaparin + clopidogrel + aspirin; Drug: bivalirudin + clopidogrel + aspirin	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	480 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients
Study Start Date :	June 2008
Estimated Primary Completion Date :	August 2012
Estimated Study Completion Date :	December 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; group without anticoagulant therapy	Drug: clopidogrel + aspirin; Other Name: Plavix Kardégic
Active Comparator: 2; group with heparin	Drug: heparin + clopidogrel + aspirin; Other Name: héparine Choay Plavix Kardégic
Active Comparator: 3; group with enoxaparin	Drug: enoxaparin + clopidogrel + aspirin; Other Name: Lovenox Plavix Kardégic
Active Comparator: 4; group with bivalirudin	Drug: bivalirudin + clopidogrel + aspirin; Other Name: Angiox Plavix Kardégic

Outcome Measures

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Primary Outcome Measures :

1. ischaemic events via troponin Ic measurements during 24 hours post procedure [ Time Frame: 24 hours ]

Secondary Outcome Measures :

1. haemorrhagic events : clinical and biological evaluation [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• stable angina pectoris or silent ischaemia

Exclusion Criteria:

• instable angina or ACS (Acute Coronary Syndrome)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Nicolas DELARCHE, MD	55-992-4883 ext 33	n.delarche@wanadoo.fr

Locations

France
Centre Hospitalier de Pau	Recruiting
PAU, Pyrénées-Atlantiques, France, 64046
Contact: Stéphane DEBEUGNY, MD 55-972-6801 ext 33 stephane.debeugny@ch-pau.fr
Principal Investigator: Nicolas DELARCHE, MD
Sub-Investigator: Raphaël LASSERRE, MD

Sponsors and Collaborators

Centre Hospitalier de PAU

Investigators

Principal Investigator:	Nicolas DELARCHE, MD	CH de Pau

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Stéphane DEBEUGNY, MD, Centre Hospitalier de PAU
ClinicalTrials.gov Identifier:	NCT00669149 History of Changes
Other Study ID Numbers:	CHPAU 2007/01
First Posted:	April 29, 2008
Last Update Posted:	July 4, 2011
Last Verified:	July 2011

Keywords provided by Centre Hospitalier de PAU:

ptca; antiaggregant therapy; anticoagulant therapy

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aspirin; Ticlopidine; Heparin; Clopidogrel; Bivalirudin; Anticoagulants; Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists