Phase 3
N=129
Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI
Acute Coronary Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00464087 ↗Enrolled (actual)
129
Serious AEs
1.0%
Results posted
Aug 2013
Primary outcome: Primary: 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 — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medstar Health Research Institute
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0; 1 | — |
| PRIMARY 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 |
0; 1 | — |
| PRIMARY 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 |
0; 1 | — |
| SECONDARY 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 |
4; 4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- ST elevated myocardial infarction within the preceding 48 hours;
- Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg);
- Patients presenting on or received bivalirudin, GP IIb/IIIa inhibitors or low-molecular weight heparin within the preceding 24 hours;
- Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration.
- Patients with known conditions of bleeding diathesis or actively bleeding within the previous 6 months (GI bleed etc.);
- Known diagnosis of acute bacterial endocarditis;
- Patients with cardiogenic shock or required intra-aortic balloon pump (IABP)
- If patient is on warfarin (Coumadin) therapy;
- Patients who had a major or minor stroke (CVA or TIA) or major surgery within the past 6 months;
- 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;
- A platelet count of less than 100,000 cells/mm3;
- Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, or contrast that cannot be medically managed;
- Prior angioplasty within the previous 30 days;
- Contraindication to low-molecular weight heparin, unfractionated heparin or bivalirudin;
- Pregnant or lactating women;
- Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study;
- Currently participating in an investigational drug or another device study.
Data sourced from ClinicalTrials.gov (NCT00464087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.