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| Name | Class |
|---|---|
| Lund University | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bivalirudin | Experimental | bivalirudin as intravenous bolus of 0,75 mg per kilogram followed by an infusion of 1,75 mg per kilogram per hour |
|
| heparin | Active Comparator | unfractionated Heparin 5 000 IU/ml as intravenous bolus according to local practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bivalirudin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Death, Myocardial infarction and major bleeding event | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Time to individual components of the primary end point (death, myocardial infarction and major bleeding). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Erlinge | Lund University, Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lund University | Lund | 221 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38575449 | Derived | 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. | |
| 34903034 |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
|
| Heparin | 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 |
|
|
| 180 days |
| Number of events where primary endpoints (death, myocardial infarction and major bleeding event) and stroke have been registered | The primary end point combined with stroke as reported in the Swedish national patient registry. | 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 |
| Time to re-hospitalization with reinfarction | Time to re-hospitalization with reinfarction as reported in Swedeheart | 180 days |
| Time to all-cause death or re-hospitalization with myocardial infarction | 180 days |
| Time to target vessel revascularization | Time to target vessel revascularization as reported in SWEDEHEART. | 180 days |
| Time to target lesion revascularization | Time to target lesion revascularization as reported in SWEDEHEART | 180 days |
| Time to stent thrombosis | Time to stent thrombosis as reported in SWEDEHEART. | 180 days |
| Time to restenosis | Time to restenosis as reported in SWEDEHEART. | 180 days |
| Time to re-hospitalization with heart failure | Time to re-hospitalization with heart failure as reported in SWEDEHEART. | 180 days |
| Heart failure and complications of PCI during index hospitalization | Heart failure and complications of PCI during index hospitalization as reported in SWEDEHEART | 180 days |
| Minor bleeding during index hospitalization | Minor bleeding during index hospitalization as reported in SWEDEHEART | 180 days |
| Length of index hospital stay | Length of index hospital stay as reported in SWEDEHEART | 180 days |
| Bail-out use of GpIIb/IIIa | Bail-out use of GpIIb/IIIa inhibitors during PCI | 180 days |
| Derived |
| 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. |
| 34514849 | Derived | 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. |
| 34011198 | Derived | 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. |
| 33589539 | Derived | 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. |
| 32143733 | Derived | 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. |
| 31387441 | Derived | 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. |
| 28844201 | Derived | 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. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |