Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)

May 15, 2019 updated by: Centre Hospitalier de PAU

Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Pyrénées-Atlantiques
      • PAU, Pyrénées-Atlantiques, France, 64046
        • Centre Hospitalier de Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stable angina pectoris or silent ischaemia

Exclusion Criteria:

  • instable angina or ACS (Acute Coronary Syndrome)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
group without anticoagulant therapy
Drug: clopidogrel + aspirin
Other Names:
  • Plavix Kardégic
Active Comparator: 2
group with heparin
Drug: heparin + clopidogrel + aspirin
Other Names:
  • héparine Choay Plavix Kardégic
Active Comparator: 3
group with enoxaparin
Drug: enoxaparin + clopidogrel + aspirin
Other Names:
  • Lovenox Plavix Kardégic
Active Comparator: 4
group with bivalirudin
Drug: bivalirudin + clopidogrel + aspirin
Other Names:
  • Angiox Plavix Kardégic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ischaemic events via troponin Ic measurements during 24 hours post procedure
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
haemorrhagic events : clinical and biological evaluation
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de PAU

Investigators

  • Principal Investigator: Nicolas DELARCHE, MD, CH de Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 3, 2013

Study Completion (Actual)

August 3, 2013

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Actual)

May 17, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHPAU 2007/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on clopidogrel + aspirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe