Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2011 by Centre Hospitalier de PAU.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Centre Hospitalier de PAU

ClinicalTrials.gov Identifier:

NCT00669149

First received: April 25, 2008

Last updated: July 1, 2011

Last verified: July 2011

History of Changes

Purpose

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	Intervention	Phase
Coronary Artery Disease	Drug: clopidogrel + aspirin Drug: heparin + clopidogrel + aspirin Drug: enoxaparin + clopidogrel + aspirin Drug: bivalirudin + clopidogrel + aspirin	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Blood Thinners

U.S. FDA Resources

Further study details as provided by Centre Hospitalier de PAU:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	480
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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, …).

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669149

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


Responsible Party:	Stéphane DEBEUGNY, MD, Centre Hospitalier de PAU
ClinicalTrials.gov Identifier:	NCT00669149 History of Changes
Other Study ID Numbers:	CHPAU 2007/01
Study First Received:	April 25, 2008
Last Updated:	July 1, 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

ClinicalTrials.gov processed this record on September 21, 2017

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