Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin

This study has been completed.
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00842374
First received: February 11, 2009
Last updated: April 24, 2013
Last verified: April 2013

February 11, 2009
April 24, 2013
December 2008
December 2011   (final data collection date for primary outcome measure)
Incidence of MACE defined as any one of the following: • Acute myocardial infarction/reinfarction • Ischemia-driven unplanned revascularizations • Stroke • All cause Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00842374 on ClinicalTrials.gov Archive Site
  • Rehospitalization for ACS [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 30 days, one year and up to 5 years ] [ Designated as safety issue: No ]
  • Major Bleeding [ Time Frame: in hospital and at 30 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin
Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin

This is a registry of patients with non ST segment elevation Myocardial Infarction (heart attack) and/or unstable acute coronary artery syndrome treated with a standardized protocol including Bivalirudin.

Data will be collected on diagnosis, treatment and outcomes.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Emergency Department

Non-STEMI Acute Coronary Syndrome
Not Provided
Non-STEMI ACS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18
  • Chest pain or symptoms believed to be an anginal equivalent and representing myocardial ischemia, lasting at least 10 minutes within the past 24 hours
  • Having any one of the following:

    1. Ischemic changes on ECG: ST depression >0.5 mm OR T wave inversion >2 mm
    2. Positive cardiac markers
    3. New onset CHF presumed secondary to ischemia
    4. Pulmonary edema
    5. Known coronary artery disease with typical symptoms
    6. Hemodynamic instability
    7. Sustained ventricular tachycardia

Exclusion Criteria:

  • For the purpose of the SSDI, patients will be excluded if we are unable to obtain their Social Security Number.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00842374
acs001
No
Minneapolis Heart Institute Foundation
Minneapolis Heart Institute Foundation
The Medicines Company
Principal Investigator: David M Larson, MD Minneapolis Heart Institute Foundation
Minneapolis Heart Institute Foundation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP