NCT00616460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

3.7 years

First QC Date

February 5, 2008

Last Update Submit

June 11, 2015

Conditions

Hematologic Diseases

Keywords

safetyefficacy

Outcome Measures

Primary Outcomes (1)

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

    30 days

Secondary Outcomes (1)

  • End points: Secondary: 30 days MACE

    30 days

Study Arms (1)

Bivalirudin

EXPERIMENTAL
Drug: Bivalirudin

Interventions

BivalirudinDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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;

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute haEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Hematologic Diseases

Interventions

bivalirudin

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

  • Yoav Turgeman, MD

    Heart Institute HaEmek medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiology Department

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

February 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

IL(1)