Anticoagulant Treatments and Percutaneous Coronary Angioplasty - Full Text View

Sponsor:	Centre Hospitalier de PAU
Information provided by:	Centre Hospitalier de PAU
ClinicalTrials.gov Identifier:	NCT00669149

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Coronary Artery Disease

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate Bivalirudin Enoxaparin Sodium Heparin

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

haemorrhagic events : clinical and biological evaluation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:	Both
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

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

No publications provided

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

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
Heparin
Enoxaparin
Clopidogrel
Bivalirudin
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012