ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAt... | NCT00616460

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

NCT00616460

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Jun 12, 2015Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

Hematologic Diseases

Interventions

Bivalirudin

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Feb 5, 2008

First Submission Date that Met QC Criteria

Feb 14, 2008

First Posted Date

Feb 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2015

Last Update Posted Date

Jun 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bivalirudin	Experimental		Drug: Bivalirudin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	Bivalirudin

Measure	Description	Time Frame
End points: Primary :Major & minor bleeding Port of entry related complications		30 days

Measure	Description	Time Frame
End points: Secondary: 30 days MACE		30 days

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided