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Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Centre Hospitalier de PAU.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier de PAU
ClinicalTrials.gov Identifier:
NCT00669149
First received: April 25, 2008
Last updated: July 1, 2011
Last verified: July 2011

April 25, 2008
July 1, 2011
June 2008
August 2012   (final data collection date for primary outcome measure)
ischaemic events via troponin Ic measurements during 24 hours post procedure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00669149 on ClinicalTrials.gov Archive Site
haemorrhagic events : clinical and biological evaluation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Anticoagulant Treatments and Percutaneous Coronary Angioplasty
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.

  • 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, …).
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: clopidogrel + aspirin
    Other Name: Plavix Kardégic
  • Drug: heparin + clopidogrel + aspirin
    Other Name: héparine Choay Plavix Kardégic
  • Drug: enoxaparin + clopidogrel + aspirin
    Other Name: Lovenox Plavix Kardégic
  • Drug: bivalirudin + clopidogrel + aspirin
    Other Name: Angiox Plavix Kardégic
  • Experimental: 1
    group without anticoagulant therapy
    Intervention: Drug: clopidogrel + aspirin
  • Active Comparator: 2
    group with heparin
    Intervention: Drug: heparin + clopidogrel + aspirin
  • Active Comparator: 3
    group with enoxaparin
    Intervention: Drug: enoxaparin + clopidogrel + aspirin
  • Active Comparator: 4
    group with bivalirudin
    Intervention: Drug: bivalirudin + clopidogrel + aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
December 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • stable angina pectoris or silent ischaemia

Exclusion Criteria:

  • instable angina or ACS (Acute Coronary Syndrome)
Both
18 Years and older
No
Contact: Nicolas DELARCHE, MD 55-992-4883 ext 33 n.delarche@wanadoo.fr
France
 
NCT00669149
CHPAU 2007/01
Yes
Stéphane DEBEUGNY, MD, Centre Hospitalier de PAU
Centre Hospitalier de PAU
Not Provided
Principal Investigator: Nicolas DELARCHE, MD CH de Pau
Centre Hospitalier de PAU
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP