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

NCT ID: NCT02311231

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 6012 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-03-31

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.

Conditions

ST-segment Elevation Myocardial Infarction; Non ST-segment Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bivalirudin

bivalirudin as intravenous bolus of 0,75 mg per kilogram followed by an infusion of 1,75 mg per kilogram per hour

Group Type: EXPERIMENTAL

bivalirudin

Intervention Type: DRUG

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.

heparin

unfractionated Heparin 5 000 IU/ml as intravenous bolus according to local practice

Group Type: ACTIVE_COMPARATOR

Heparin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Angiox; Heparin 5000 IU/ml i.v. ,Leo Pharma

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Erlinge

Role: PRINCIPAL_INVESTIGATOR

Lund University, Lund, Sweden

Locations

Lund University

Lund, , Sweden

Countries

Sweden

References

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Reference Type: DERIVED

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James S, Koul S, Andersson J, Angeras O, Bhiladvala P, Calais F, Danielewicz M, Frobert O, Grimfjard P, Gotberg M, Henareh L, Ioanes D, Jensen J, Linder R, Lindroos P, Omerovic E, Panayi G, Ramunddal T, Sarno G, Ulvenstam A, Voltz S, Wagner H, Wikstrom H, Ostlund O, Erlinge D. Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2021 Dec;14(12):e008969. doi: 10.1161/CIRCINTERVENTIONS.120.008969. Epub 2021 Dec 14.

Reference Type: DERIVED

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Bergman S, Mohammad MA, James SK, Angeras O, Wagner H, Jensen J, Schersten F, Frobert O, Koul S, Erlinge D. Clinical Impact of Intraprocedural Stent Thrombosis During Percutaneous Coronary Intervention in Patients Treated With Potent P2Y12 inhibitors - a VALIDATE-SWEDEHEART Substudy. J Am Heart Assoc. 2021 Sep 21;10(18):e022984. doi: 10.1161/JAHA.121.022984. Epub 2021 Sep 13.

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Jamaly S, Redfors B, Omerovic E, Carlsson L, Karason K. Prognostic significance of BMI after PCI treatment in ST-elevation myocardial infarction: a cohort study from the Swedish Coronary Angiography and Angioplasty Registry. Open Heart. 2021 Feb;8(1):e001479. doi: 10.1136/openhrt-2020-001479.

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Olsson A, Ring C, Josefsson J, Eriksson A, Rylance R, Frobert O, James S, Sparv D, Erlinge D. Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial. Trials. 2020 Mar 6;21(1):246. doi: 10.1186/s13063-020-4147-0.

Reference Type: DERIVED

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Wester A, Attar R, Mohammad MA, Andell P, Hofmann R, Jensen J, Szummer K, Erlinge D, Koul S. Impact of Baseline Anemia in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: A Prespecified Analysis From the VALIDATE-SWEDEHEART Trial. J Am Heart Assoc. 2019 Aug 20;8(16):e012741. doi: 10.1161/JAHA.119.012741. Epub 2019 Aug 7.

Reference Type: DERIVED

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Erlinge D, Omerovic E, Frobert O, Linder R, Danielewicz M, Hamid M, Swahn E, Henareh L, Wagner H, Hardhammar P, Sjogren I, Stewart J, Grimfjard P, Jensen J, Aasa M, Robertsson L, Lindroos P, Haupt J, Wikstrom H, Ulvenstam A, Bhiladvala P, Lindvall B, Lundin A, Todt T, Ioanes D, Ramunddal T, Kellerth T, Zagozdzon L, Gotberg M, Andersson J, Angeras O, Ostlund O, Lagerqvist B, Held C, Wallentin L, Schersten 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.

Reference Type: DERIVED

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Other Identifiers

EudraCT nr: 2012-005260-10

Identifier Type: -

Identifier Source: org_study_id