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Trial record 38 of 993 for:    Heparin sodium

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

Tracking Information
First Submitted Date  ICMJE November 27, 2014
First Posted Date  ICMJE December 8, 2014
Last Update Posted Date May 19, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
Death, Myocardial infarction and major bleeding event [ Time Frame: 180 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02311231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
  • Death, Myocardial infarction and major bleeding events in the subgroups NSTEMI and STEMI [ Time Frame: 180 days ]
  • 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).
  • 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.
  • 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 ]
  • TIMI flow grade after PCI [ Time Frame: 180 days ]
  • Time to re-hospitalization with reinfarction [ Time Frame: 180 days ]
    Time to re-hospitalization with reinfarction as reported in Swedeheart
  • Time to all-cause death or re-hospitalization with myocardial infarction [ Time Frame: 180 days ]
  • Time to target vessel revascularization [ Time Frame: 180 days ]
    Time to target vessel revascularization as reported in SWEDEHEART.
  • Time to target lesion revascularization [ Time Frame: 180 days ]
    Time to target lesion revascularization as reported in SWEDEHEART
  • Time to stent thrombosis [ Time Frame: 180 days ]
    Time to stent thrombosis as reported in SWEDEHEART.
  • Time to restenosis [ Time Frame: 180 days ]
    Time to restenosis as reported in SWEDEHEART.
  • Time to re-hospitalization with heart failure [ Time Frame: 180 days ]
    Time to re-hospitalization with heart failure as reported in SWEDEHEART.
  • 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
  • Minor bleeding during index hospitalization [ Time Frame: 180 days ]
    Minor bleeding during index hospitalization as reported in SWEDEHEART
  • Length of index hospital stay [ Time Frame: 180 days ]
    Length of index hospital stay as reported in SWEDEHEART
  • Bail-out use of GpIIb/IIIa [ Time Frame: 180 days ]
    Bail-out use of GpIIb/IIIa inhibitors during PCI
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
  • Death, Myocardial infarction and major bleeding events in the subgroups NSTEMI and STEMI [ Time Frame: 180 days ]
  • 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).
  • 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.
  • 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 ]
  • TIMI flow grade after PCI [ Time Frame: 180 days ]
  • Time to re-hospitalization with reinfarction [ Time Frame: 180 days ]
    Time to re-hospitalization with reinfarction as reported in Swedeheart
  • Time to all-cause death or re-hospitalization with myocardial infarction [ Time Frame: 180 days ]
  • Time to target vessel revascularization [ Time Frame: 180 days ]
    Time to target vessel revascularization as reported in SWEDEHEART.
  • Time to target lesion revascularization [ Time Frame: 180 days ]
    Time to target lesion revascularization as reported in SWEDEHEART
  • Time to stent thrombosis [ Time Frame: 180 days ]
    Time to stent thrombosis as reported in SWEDEHEART.
  • Time to restenosis [ Time Frame: 180 days ]
    Time to restenosis as reported in SWEDEHEART.
  • Time to re-hospitalization with heart failure [ Time Frame: 180 days ]
    Time to re-hospitalization with heart failure as reported in SWEDEHEART.
  • 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
  • Minor bleeding during index hospitalization [ Time Frame: 180 days ]
    Minor bleeding during index hospitalization as reported in SWEDEHEART
  • Length of index hospital stay [ Time Frame: 180 days ]
    Length of index hospital stay as reported in SWEDEHEART
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • ST-segment Elevation Myocardial Infarction
  • Non ST-segment Elevation Myocardial Infarction
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: bivalirudin
    bivalirudin as intravenous bolus of 0,75 mg per kilogram followed by an infusion of 1,75 mg per kilogram per hour
    Intervention: Drug: bivalirudin
  • Active Comparator: heparin
    unfractionated Heparin 5 000 IU/ml as intravenous bolus according to local practice
    Intervention: Drug: Heparin
Publications * Erlinge D, Omerovic E, Fröbert O, Linder R, Danielewicz M, Hamid M, Swahn E, Henareh L, Wagner H, Hårdhammar P, Sjögren I, Stewart J, Grimfjärd P, Jensen J, Aasa M, Robertsson L, Lindroos P, Haupt J, Wikström H, Ulvenstam A, Bhiladvala P, Lindvall B, Lundin A, Tödt T, Ioanes D, Råmunddal T, Kellerth T, Zagozdzon L, Götberg M, Andersson J, Angerås O, Östlund O, Lagerqvist B, Held C, Wallentin L, Scherstén F, Eriksson P, Koul S, James S. Bivalirudin versus Heparin Monotherapy in Myocardial Infarction. N Engl J Med. 2017 Sep 21;377(12):1132-1142. doi: 10.1056/NEJMoa1706443. Epub 2017 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2016)
6012
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2014)
6000
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02311231
Other Study ID Numbers  ICMJE EudraCT nr: 2012-005260-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Lund University
Investigators  ICMJE
Principal Investigator: David Erlinge Lund University, Lund, Sweden
PRS Account Uppsala University
Verification Date May 2017

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