Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669149
Recruitment Status : Unknown
Verified July 2011 by Centre Hospitalier de PAU.
Recruitment status was:  Recruiting
First Posted : April 29, 2008
Last Update Posted : July 4, 2011
Information provided by:
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.

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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 ]

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

Inclusion Criteria:

  • stable angina pectoris or silent ischaemia

Exclusion Criteria:

  • instable angina or ACS (Acute Coronary Syndrome)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00669149

Contact: Nicolas DELARCHE, MD 55-992-4883 ext 33

Centre Hospitalier de Pau Recruiting
PAU, Pyrénées-Atlantiques, France, 64046
Contact: Stéphane DEBEUGNY, MD    55-972-6801 ext 33   
Principal Investigator: Nicolas DELARCHE, MD         
Sub-Investigator: Raphaël LASSERRE, MD         
Sponsors and Collaborators
Centre Hospitalier de PAU
Principal Investigator: Nicolas DELARCHE, MD CH de Pau

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

Keywords provided by Centre Hospitalier de PAU:
antiaggregant therapy
anticoagulant therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Purinergic P2Y Receptor Antagonists