Reduced Dose of Unfractionated Heparin in Patients Undergoing PCI (ISAR-REACT-3A)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00735280
First received: August 12, 2008
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

The aim of this trial is to evaluate whether a reduction in the heparin dose from 140 to 100 U/kg is associated with a better net clinical outcome in patients undergoing PCI after pretreatment with 600mg clopidogrel


Condition Intervention Phase
Coronary Artery Disease
Drug: unfractionated heparin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-randomized, Open-label, Historical Control, Single Group Assignment Trial of a Reduced Dose of Unfractionated Heparin in Patients Undergoing Percutaneous Coronary Interventions

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • The primary outcome measure will be a composite of death, MI, urgent TVR after 30 days or in hospital bleeding (quadruple endpoint, "net clinical benefit"). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite of death, MI or urgent TVR (Triple endpoint to assess ischemic complications) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Composite of death, MI or TVR [ Time Frame: 1 year after the index procedure ] [ Designated as safety issue: Yes ]

Enrollment: 2505
Study Start Date: August 2008
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reduced dose of unfractionated heparin Drug: unfractionated heparin
bolus of 100 U/kg of unfractionated heparin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients older than 18 years undergoing a PCI procedure
  2. Pretreatment with 600mg clopidogrel at least 2 hours before the intervention
  3. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

  1. Recent ST-elevation myocardial infarction within the last 48 hours
  2. Acute coronary syndromes with positive biomarkers (Troponin T > 0.03 μg/L or CK-MB > ULN)
  3. Cardiogenic shock
  4. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance
  5. Active bleeding; bleeding diathesis
  6. History of gastrointestinal or genitourinary bleeding within the last 6 weeks
  7. Presence of diseases which have a high probability of vascular lesions and subsequent bleeding such as active gastric ulcer or active ulcerous colitis
  8. Recent trauma or major surgery in the last month
  9. Ophthalmic surgery or brain surgery in the last month
  10. Retinopathies or vitreous body bleeding in the last month
  11. History of intracranial bleeding or structural abnormalities (for example aneurysm of cerebral arteries)
  12. Suspected aortic dissection; pericarditis and subacute bacterial endocarditis
  13. Patient's refusal to blood transfusion.
  14. Oral anticoagulation therapy with coumarin derivative within the last 7 days
  15. Treatment with UFH within 6 hours unless an ACT is less than 150 sec or low-molecular weight heparin within 8 hours before enrollment
  16. Treatment with bivalirudin within 24 hours before enrollment
  17. Severe uncontrolled hypertension >180/110 mmHg unresponsive to therapy
  18. Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days.
  19. Relevant hematologic deviations: hemoglobin < 100 g/L, platelet count < 100 x 109 /L.
  20. Glomerular filtration rate (GFR) < 30 ml/min or serum creatinine > 30 mg/L or dependence on renal dialysis.
  21. Known allergy to the study medications: aspirin, clopidogrel, UFH, true anaphylaxis after prior exposure to contrast media.
  22. Known heparin-induced thrombocytopenia (Typ II)
  23. Previous enrollment in this trial.
  24. Pregnancy (present, suspected or planned) or positive pregnancy test.
  25. Spinal, peridural and epidural anesthesia
  26. Patient's inability to fully cooperate with the study protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735280

Locations
Germany
Herz-Zentrum
Bad Krozingen, Germany, 79189
Deutsches Herzzentrum München
München, Germany, 81541
Klinikum rechts der Isar der Technischen Universität München
München, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum München
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum München
  More Information

Publications:
Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB 3rd, Morrison DA, O'Neil WW, Schaff HV, Whitlow PL, Williams DO, Antman EM, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; ACC/AHA/SCAI Writing Committee to Update 2001 Guidelines for Percutaneous Coronary Intervention. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update 2001 Guidelines for Percutaneous Coronary Intervention). Circulation. 2006 Feb 21;113(7):e166-286. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00735280     History of Changes
Other Study ID Numbers: GE IDE No. A01408
Study First Received: August 12, 2008
Last Updated: January 3, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:
Coronary artery disease, stent, heparin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 22, 2014