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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Turgeman Yoav, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00616460
First received: February 5, 2008
Last updated: June 11, 2015
Last verified: June 2015
  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 ]

Enrollment: 100
Study Start Date: February 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bivalirudin 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

Locations
Israel
Heart Institute haEmek Medical Center
Afula, Israel, 18101
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: Turgeman Yoav, Chief of Cardiology Department, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00616460     History of Changes
Other Study ID Numbers: 0124-07-EMC
Study First Received: February 5, 2008
Last Updated: June 11, 2015
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
safety
efficacy

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

ClinicalTrials.gov processed this record on July 29, 2015