Current partner codePEPTIDESDE
NCT00464087·Phase 3·INTERVENTIONAL

Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI

Status

Completed

Phase

Phase 3

Enrollment

100

Locations

7

Results

Posted

Publications

0

Study summary

What the protocol is testing.

The primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty.

Full detailed description

This is a prospective open label, randomized, multi-center registry. One hundred patients who received fondaparinux within the 24 hours prior to presentation to the coronary catheterization lab and who are suitable for percutaneous coronary intervention. The patients will be randomized in a 1:1 fashion to either unfractionated heparin or bivalirudin during the angioplasty. All patients will be followed throughout the duration of the hospital stay.

Interventions

Treatment arms and agents.

DRUG

Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin

Timeline

From registration to results.

  1. First posted

    Apr 20, 2007

  2. Study start

    Jun 2007

  3. Primary completion

    Nov 2010

  4. Study completion

    Nov 2010

  5. Results posted

    Aug 1, 2013

  6. Registry updated

    Aug 1, 2013

Outcomes

What the study measures.

Primary outcomes

The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge

Time frame · During hospitalization, after Fondaparinux administration, prior to randomization

Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge

Time frame · During hospitalization, after randomization, during PCI

Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge

Time frame · During hospitalization, after PCI

Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

Secondary outcomes

Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis

Time frame · during index hospitalization

Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1\. The patient is, male or female, \> 18 years of age; 2. The patient presents with coronary syndrome, unstable angina or non ST segment elevated myocardial infarction (NSTEMI) defined as at least one of the following criteria: * Elevated creatine kinase MB or Troponin I or T (above ULN) * ECG changes indicative of ischemia 3. The patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease; 4. The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent. 1. ST elevated myocardial infarction within the preceding 48 hours; 2. Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg); 3. Patients presenting on or received bivalirudin, GP IIb/IIIa inhibitors or low-molecular weight heparin within the preceding 24 hours; 4. Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration. 5. Patients with known conditions of bleeding diathesis or actively bleeding within the previous 6 months (GI bleed etc.); 6. Known diagnosis of acute bacterial endocarditis; 7. Patients with cardiogenic shock or required intra-aortic balloon pump (IABP) 8. If patient is on warfarin (Coumadin) therapy; 9. Patients who had a major or minor stroke (CVA or TIA) or major surgery within the past 6 months; 10. Known impaired renal function (creatinine ≥ 3.0 mg/dL (265.2 μmol/L),) status post renal transplant, patients on chronic dialysis or creatinine clearance ≤ 30 ml/min; 11. A platelet count of less than 100,000 cells/mm3; 12. Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, or contrast that cannot be medically managed; 13. Prior angioplasty within the previous 30 days; 14. Contraindication to low-molecular weight heparin, unfractionated heparin or bivalirudin; 15. Pregnant or lactating women; 16. Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study; 17. Currently participating in an investigational drug or another device study.

Study locations

7 registered sites.

Canada · United States. Showing up to 24 locations stored in the fast local snapshot.

Bridgeport Hospital

Bridgeport, Connecticut, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Hamilton General Hospital

Hamilton, Ontario, Canada

Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval)

Québec, Quebec, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.