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

This study has been completed.
Information provided by (Responsible Party):
Turgeman Yoav, HaEmek Medical Center, Israel Identifier:
First received: February 5, 2008
Last updated: June 11, 2015
Last verified: June 2015
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

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

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

Secondary Outcome Measures:
  • End points: Secondary: 30 days MACE [ Time Frame: 30 days ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00616460

Heart Institute haEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Principal Investigator: Yoav Turgeman, MD Heart Institute HaEmek medical center
  More Information

Responsible Party: Turgeman Yoav, Chief of Cardiology Department, HaEmek Medical Center, Israel Identifier: NCT00616460     History of Changes
Other Study ID Numbers: 0124-07-EMC
Study First Received: February 5, 2008
Last Updated: June 11, 2015

Keywords provided by Turgeman Yoav, HaEmek Medical Center, Israel:

Additional relevant MeSH terms:
Hematologic Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents processed this record on September 21, 2017