Anticoagulant Treatments and Percutaneous Coronary Angioplasty

NCT00669149 | Terminated Phase 4 DMC

• 1 other identifier: CHPAU 2007/01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

ptca; antiaggregant therapy; anticoagulant therapy

Outcome Measures

Primary Outcomes (1)

• ischaemic events via troponin Ic measurements during 24 hours post procedure

  24 hours

Secondary Outcomes (1)

• haemorrhagic events : clinical and biological evaluation

  24 hours

Study Arms (4)

1

EXPERIMENTAL

group without anticoagulant therapy

Drug: clopidogrel + aspirin

2

ACTIVE COMPARATOR

group with heparin

Drug: heparin + clopidogrel + aspirin

3

ACTIVE COMPARATOR

group with enoxaparin

Drug: enoxaparin + clopidogrel + aspirin

4

ACTIVE COMPARATOR

group with bivalirudin

Drug: bivalirudin + clopidogrel + aspirin

Interventions

clopidogrel + aspirin DRUG

Also known as: Plavix Kardégic

1

heparin + clopidogrel + aspirin DRUG

Also known as: héparine Choay Plavix Kardégic

2

enoxaparin + clopidogrel + aspirin DRUG

Also known as: Lovenox Plavix Kardégic

3

bivalirudin + clopidogrel + aspirin DRUG

Also known as: Angiox Plavix Kardégic

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable angina pectoris or silent ischaemia

You may not qualify if:

• instable angina or ACS (Acute Coronary Syndrome)

Sponsors & Collaborators

• Centre Hospitalier de PAU: lead

Study Sites (1)

Centre Hospitalier de Pau

Pau, Pyrénées-Atlantiques, 64046, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel; Aspirin; Heparin; Enoxaparin; bivalirudin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Glycosaminoglycans; Polysaccharides; Carbohydrates; Heparin, Low-Molecular-Weight

Study Officials

• Nicolas DELARCHE, MD

  CH de Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: June 1, 2008
• Primary Completion: August 3, 2013
• Study Completion: August 3, 2013
• Last Updated: May 17, 2019

Record last verified: 2019-05

Locations

FR (1)