Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | July 2009 |
| End Date: | December 2013 |
| Contact: | Allen Jeremias, MD |
| Email: | allen.jeremias@stonybrook.edu |
| Phone: | 631-444-1393 |
STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention
The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin)
versus unfractionated heparin (UFH) in patients presenting with stable angina or silent
ischemia (positive stress test without chest pain) that undergo percutaneous coronary
intervention (PCI).
The primary endpoint of the study will be major and minor bleeding events, defined by the
REPLACE-2 trial definition, during the index hospitalization and up to 30 days post
discharge.
versus unfractionated heparin (UFH) in patients presenting with stable angina or silent
ischemia (positive stress test without chest pain) that undergo percutaneous coronary
intervention (PCI).
The primary endpoint of the study will be major and minor bleeding events, defined by the
REPLACE-2 trial definition, during the index hospitalization and up to 30 days post
discharge.
The purpose of this study is to compare in a randomized, controlled, single-blinded, 1:1
fashion UFH versus bivalirudin in patients with stable angina pectoris or silent ischemia
undergoing PCI.
Secondary study endpoints will include:
- Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial
infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral
vascular accident (CVA).
- Net adverse clinical events (NACE) will be consistent of MACE plus major bleeding as
defined by the REPLCE-2 criteria.
- Cardiac death in-hospital and up to 30 days post discharge.
- MI in-hospital and up to 30 days post discharge.
- CVA in-hospital and up to 30 days post discharge.
- Incidence of all-cause mortality at 6 months and 1 year.
- MACE at 6 months and 1 year.
- Incidence of acute (0-24 hours post procedure) stent thrombosis rates.
- Incidence of sub-acute (24 hours - 30 days) stent thrombosis rates.
- Length of hospital stay (LOS)
- Economic analysis (total cost during hospitalization) and up to 30 days post discharge.
fashion UFH versus bivalirudin in patients with stable angina pectoris or silent ischemia
undergoing PCI.
Secondary study endpoints will include:
- Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial
infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral
vascular accident (CVA).
- Net adverse clinical events (NACE) will be consistent of MACE plus major bleeding as
defined by the REPLCE-2 criteria.
- Cardiac death in-hospital and up to 30 days post discharge.
- MI in-hospital and up to 30 days post discharge.
- CVA in-hospital and up to 30 days post discharge.
- Incidence of all-cause mortality at 6 months and 1 year.
- MACE at 6 months and 1 year.
- Incidence of acute (0-24 hours post procedure) stent thrombosis rates.
- Incidence of sub-acute (24 hours - 30 days) stent thrombosis rates.
- Length of hospital stay (LOS)
- Economic analysis (total cost during hospitalization) and up to 30 days post discharge.
Inclusion Criteria:
1. The patient is male or female ≥ 18 years of age.
2. The patient presents with stable angina pectoris, or silent ischemia (positive stress
test without chest pain).
3. The patient is scheduled for coronary angiography, with possible angioplasty.
4. The patient is able to tolerate dual anti-platelet therapy with aspirin and
clopidogrel for a minimum of 30 days and is on those medications at the time of the
PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI).
5. The patient is able and willing to conform to the requirements of the study and
voluntarily signs an Informed Consent.
6. The patient does not present with any form of illness or condition that in the
investigator's opinion would impair the results of the study.
7. Women of child bearing potential must have a negative urine or serum pregnancy test
prior to enrollment.
Exclusion Criteria:
1. Patients in cardiogenic shock.
2. Patients with acute coronary syndrome, which includes unstable angina,
non-ST-elevation MI or STEMI.
3. Known history of heparin-induced thrombocytopenia.
4. Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or
antithrombotic pharmacological agent.
5. Any significant medical condition, which in the investigator's opinion, may interfere
with the patient's optimal participation in the study.
6. Pregnant women or nursing mothers.
We found this trial at
1
site
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
Click here to add this to my saved trials
