NCT02311231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,012

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

November 27, 2014

Last Update Submit

May 18, 2017

Conditions

ST-segment Elevation Myocardial InfarctionNon ST-segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Death, Myocardial infarction and major bleeding event

    180 days

Secondary Outcomes (16)

  • Death, Myocardial infarction and major bleeding events in the subgroups NSTEMI and STEMI

    180 days

  • Time to primary endpoints (death, myocardial infarction and major bleeding event)

    180 days

  • Number of events where primary endpoints (death, myocardial infarction and major bleeding event) and stroke have been registered

    180 days

  • 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)

    180 days

  • TIMI flow grade after PCI

    180 days

  • +11 more secondary outcomes

Study Arms (2)

bivalirudin

EXPERIMENTAL

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

Drug: bivalirudin

heparin

ACTIVE COMPARATOR

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

Drug: Heparin

Interventions

bivalirudinDRUG

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.

Also known as: Angiox
bivalirudin
HeparinDRUG

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

Also known as: Heparin 5000 IU/ml i.v. ,Leo Pharma
heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, 221 85, Sweden

Location

Related Publications (8)

  • Omerovic E, James S, Ramundal T, Frobert O, Linder R, Danielewicz M, Hamid M, Pagonis C, Henareh L, Wagner H, Stewart J, Jensen J, Lindros P, Robertsson L, Wikstrom H, Ulvenstam A, Bhiladval P, Todt T, Ioanes D, Kellerth T, Zagozdzon L, Gotberg M, Andersson J, Angeras O, Ostlund O, Held C, Koul S, Erlinge D. Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction-Outcomes at two years. Cardiovasc Revasc Med. 2024 Sep;66:43-50. doi: 10.1016/j.carrev.2024.03.025. Epub 2024 Mar 26.

    PMID: 38575449DERIVED

  • 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.

    PMID: 34903034DERIVED

  • 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.

    PMID: 34514849DERIVED

  • Rylance RT, Wagner P, Omerovic E, Held C, James S, Koul S, Erlinge D. Assessing the external validity of the VALIDATE-SWEDEHEART trial. Clin Trials. 2021 Aug;18(4):427-435. doi: 10.1177/17407745211012438. Epub 2021 May 20.

    PMID: 34011198DERIVED

  • 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.

    PMID: 33589539DERIVED

  • 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.

    PMID: 32143733DERIVED

  • 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.

    PMID: 31387441DERIVED

  • 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.

    PMID: 28844201DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

bivalirudinHeparin

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • David Erlinge

    Lund University, Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 8, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 19, 2017

Record last verified: 2017-05

Locations

SE(1)