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Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART (VALIDATE)

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ClinicalTrials.gov Identifier: NCT02311231
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.

Condition or disease Intervention/treatment Phase
ST-segment Elevation Myocardial Infarction Non ST-segment Elevation Myocardial Infarction Drug: bivalirudin Drug: Heparin Phase 4

Detailed Description:

The follow up of endpoints will be performed using SWEDEHEART and national registries. Follow up of primary endpoints and stroke will also be performed by telephone contacts with the patients or first degree relatives by a nurse phone call after 7 days and 180 days. The nurses will also accumulate hospital record information on these endpoints.

A central adjudication will be performed for all reported primary endpoints for the first 180 days follow up. Every site will prepare source documents for the event and send it to UCR for central adjudication by an independent committee.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6012 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the SWEDEHEART Platform
Study Start Date : June 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: bivalirudin
bivalirudin as intravenous bolus of 0,75 mg per kilogram followed by an infusion of 1,75 mg per kilogram per hour
Drug: bivalirudin
Will be administered as an intravenous bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour). Bivalirudin will be administered alone or with a low dose of heparin up to 3000U heparin in lab or up to 5000 U given pre-hospital according to local practice.
Other Name: Angiox

Active Comparator: heparin
unfractionated Heparin 5 000 IU/ml as intravenous bolus according to local practice
Drug: Heparin
Treatment with unfractionated Heparin 5000 IU/ml i.v. ,Leo Pharma, Sweden, (the control group). Heparin in the control group is administered as an intravenous or intra-arterial bolus according to local practice. A dose of 70-100 U/kg is recommended
Other Name: Heparin 5000 IU/ml i.v. ,Leo Pharma




Primary Outcome Measures :
  1. Death, Myocardial infarction and major bleeding event [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Death, Myocardial infarction and major bleeding events in the subgroups NSTEMI and STEMI [ Time Frame: 180 days ]
  2. Time to primary endpoints (death, myocardial infarction and major bleeding event) [ Time Frame: 180 days ]
    Time to individual components of the primary end point (death, myocardial infarction and major bleeding).

  3. Number of events where primary endpoints (death, myocardial infarction and major bleeding event) and stroke have been registered [ Time Frame: 180 days ]
    The primary end point combined with stroke as reported in the Swedish national patient registry.

  4. Number of events where primary endpoints (death, myocardial infarction and major bleeding event) have been registered in heparin subgroups (U/kg, groups with certain max ACT values etc) [ Time Frame: 180 days ]
  5. TIMI flow grade after PCI [ Time Frame: 180 days ]
  6. Time to re-hospitalization with reinfarction [ Time Frame: 180 days ]
    Time to re-hospitalization with reinfarction as reported in Swedeheart

  7. Time to all-cause death or re-hospitalization with myocardial infarction [ Time Frame: 180 days ]
  8. Time to target vessel revascularization [ Time Frame: 180 days ]
    Time to target vessel revascularization as reported in SWEDEHEART.

  9. Time to target lesion revascularization [ Time Frame: 180 days ]
    Time to target lesion revascularization as reported in SWEDEHEART

  10. Time to stent thrombosis [ Time Frame: 180 days ]
    Time to stent thrombosis as reported in SWEDEHEART.

  11. Time to restenosis [ Time Frame: 180 days ]
    Time to restenosis as reported in SWEDEHEART.

  12. Time to re-hospitalization with heart failure [ Time Frame: 180 days ]
    Time to re-hospitalization with heart failure as reported in SWEDEHEART.

  13. Heart failure and complications of PCI during index hospitalization [ Time Frame: 180 days ]
    Heart failure and complications of PCI during index hospitalization as reported in SWEDEHEART

  14. Minor bleeding during index hospitalization [ Time Frame: 180 days ]
    Minor bleeding during index hospitalization as reported in SWEDEHEART

  15. Length of index hospital stay [ Time Frame: 180 days ]
    Length of index hospital stay as reported in SWEDEHEART

  16. Bail-out use of GpIIb/IIIa [ Time Frame: 180 days ]
    Bail-out use of GpIIb/IIIa inhibitors during PCI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or, patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
  • PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI).
  • Treated with bolus dose of ticagrelor or prasugrel before start of PCI. See 2.6
  • Ability to provide informed consent
  • Age 18 years or older

Exclusion Criteria:

  • Previous randomization in the VALIDATE-SWEDEHEART trial.
  • Known terminal disease with life expectancy less than one year.
  • Patients with known ongoing bleeding
  • Patients with uncontrolled hypertension in the opinion of the investigator
  • Patients with known subacute bacterial endocarditis
  • Patients with known severe renal (GFR < 30 ml/min) and/or liver dysfunction
  • Patients with known thrombocytopenia or thrombocyte function defects
  • Any other contraindication for the study medications.
  • Heparin > 5000U Before arriving to PCI lab or > 3000 U given during angiography before randomization.
  • GpIIb/IIIa inhibitors have been given or are pre-planned to be given during the procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311231


Locations
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Sweden
Lund University
Lund, Sweden, 221 85
Sponsors and Collaborators
Uppsala University
Lund University
Investigators
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Principal Investigator: David Erlinge Lund University, Lund, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02311231     History of Changes
Other Study ID Numbers: EudraCT nr: 2012-005260-10
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heparin
Calcium heparin
Bivalirudin
Hirudins
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors