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Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)

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ClinicalTrials.gov Identifier: NCT00669149
Recruitment Status : Terminated (recruitment difficulties)
First Posted : April 29, 2008
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de PAU

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)
Actual Enrollment : 99 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
Actual Primary Completion Date : August 3, 2013
Actual Study Completion Date : August 3, 2013

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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, Older Adult)
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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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 ClinicalTrials.gov identifier (NCT number): NCT00669149


Locations
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France
Centre Hospitalier de Pau
PAU, Pyrénées-Atlantiques, France, 64046
Sponsors and Collaborators
Centre Hospitalier de PAU
Investigators
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Principal Investigator: Nicolas DELARCHE, MD CH de Pau
More Information
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Responsible Party: Centre Hospitalier de PAU
ClinicalTrials.gov Identifier: NCT00669149     History of Changes
Other Study ID Numbers: CHPAU 2007/01
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Keywords provided by Centre Hospitalier de PAU:
ptca
antiaggregant therapy
anticoagulant therapy
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Heparin
Bivalirudin
Clopidogrel
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
Purinergic P2 Receptor Antagonists