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

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.

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Key information

Conditions

Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Heart Institute haEmek Medical Center

Afula, 18101, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)

Treatment and study plan

Bivalirudin

Drug

Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT < 250

Primary outcomes

End points: Primary :Major & minor bleeding Port of entry related complications

Time frame: 30 days

Secondary outcomes

End points: Secondary: 30 days MACE

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Acronym: ACRIPAB

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Feb 15, 2008
Registry last updated: Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed