Reduced Dose of Unfractionated Heparin in Patients Undergoing PCI

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Treatments: Calcium heparin; Heparin

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.