ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00616460
First received: February 5, 2008
Last updated: February 14, 2008
Last verified: February 2008
  Purpose

To determine the safety/efficacy of Bivallirudin Vs unfractionated heparin (UFH) on top of dual antiplatelet therapy in patients with high tendency for bleeding during urgent and elective PCI.


Condition Intervention Phase
Hematologic Diseases
Drug: Bivalirudin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • End points: Primary :Major & minor bleeding Port of entry related complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • End points: Secondary: 30 days MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bivalirudin
    Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT < 250
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria (any of the following):

  • ≥75 years
  • Creatinin clearance rate < 60 ml per minute
  • Anemia (Hb 9-11 mg%)
  • Hypertension: BP > 180/95 mmHg but less than 210/110 m Hg
  • Diabetic Pts
  • Steroid treated Pts
  • Recent (within 6 weeks) non major surgery
  • Pts with hematological disorders associated with tendency for bleeding like Thrombocytopenia (platelets 50000-150000) included TTP;

Exclusion Criteria:

Exclusion criteria:

  • Age < 18 year
  • Acute STEMI (Primary PCI)*
  • Rescue angioplasty <12h after lytic therapy*
  • Active bleeding
  • S.C LMWH < 8 hours or UFH < 4 hours before PCI
  • Using IIb /IIIa as an upstream therapy before PCI
  • PCI which will be involved with obligatory IIb /IIIa therapy:

(thrombotic complication, occlusive dissection)

  • INR>1.5 on day of cathetrization
  • Bolus of 600mg of Clopidogrel before PCI
  • Current pregnancy or women in reproductive age without contraceptives
  • Hypersensitivity to heparin or bivalirudin or its components *(possible using IIB/IIIA)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616460

Contacts
Contact: Alexander Feldman, MD 972-4-6495275 feldman_al@clalit.org.il

Locations
Israel
Heart Institute haEmek Medical Center Not yet recruiting
Afula, Israel, 18101
Contact: Alexander Feldman, MD    972-4-6495273    feldman_al@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Yoav Turgeman, MD Heart Institute HaEmek medical center
  More Information

No publications provided

Responsible Party: Dr Yoav Turgeman, Heart Institute, HaEmek Medical Center
ClinicalTrials.gov Identifier: NCT00616460     History of Changes
Other Study ID Numbers: 0124-07-EMC
Study First Received: February 5, 2008
Last Updated: February 14, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
safety
efficacy

Additional relevant MeSH terms:
Hematologic Diseases
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014