Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 25, 2008
First Posted Date  ICMJE April 29, 2008
Last Update Posted Date May 17, 2019
Study Start Date  ICMJE June 2008
Actual Primary Completion Date August 3, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2008)
ischaemic events via troponin Ic measurements during 24 hours post procedure [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00669149 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2008)
haemorrhagic events : clinical and biological evaluation [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulant Treatments and Percutaneous Coronary Angioplasty
Official Title  ICMJE Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 15, 2019)
99
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2008)
480
Actual Study Completion Date  ICMJE August 3, 2013
Actual Primary Completion Date August 3, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • stable angina pectoris or silent ischaemia

Exclusion Criteria:

  • instable angina or ACS (Acute Coronary Syndrome)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00669149
Other Study ID Numbers  ICMJE CHPAU 2007/01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier de PAU
Study Sponsor  ICMJE Centre Hospitalier de PAU
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicolas DELARCHE, MD CH de Pau
PRS Account Centre Hospitalier de PAU
Verification Date May 2019

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