drugset / Trial / NCT02257294
A Trial of Low-dose Adjunctive alTeplase During prIMary PCI
Phase 2
Completed
440 enrolled
NHS Greater Glasgow and Clyde
National Institute for Health Research, United Kingdom · collabUniversity of Glasgow · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine the safety and efficacy of reduced doses (10 mg and 20 mg) of intra-coronary alteplase compared with placebo as an adjunct to PCI in reducing MVO and its consequences in high risk patients with STEMI.
Timeline
- Start
- 2016-03
- Primary completion
- 2018-07
- Completion
- 2019-05-08
Publications
- Bulluck H, Carberry J, Carrick D, McCartney PJ, Maznyczka AM, Greenwood JP, Maredia N, Chowdhary S, Gershlick AH, Appleby C, Cotton JM, Wragg A, Curzen N, McEntegart M, Petrie MC, Eteiba H, Watkins S, Lindsay M, Mahrous A, Oldroyd KG, Berry C. A Noncontrast CMR Risk Score for Long-Term Risk Stratification in Reperfused ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Imaging. 2022 Mar;15(3):431-440. doi: 10.1016/j.jcmg.2021.08.006. Epub 2022 Jan 12.
- Maznyczka AM, McCartney PJ, Oldroyd KG, Lindsay M, McEntegart M, Eteiba H, Rocchiccioli JP, Good R, Shaukat A, Robertson K, Malkin CJ, Greenwood JP, Cotton JM, Hood S, Watkins S, Collison D, Gillespie L, Ford TJ, Weir RAP, McConnachie A, Berry C. Risk Stratification Guided by the Index of Microcirculatory Resistance and Left Ventricular End-Diastolic Pressure in Acute Myocardial Infarction. Circ Cardiovasc Interv. 2021 Feb;14(2):e009529. doi: 10.1161/CIRCINTERVENTIONS.120.009529. Epub 2021 Feb 16.
- Maznyczka AM, McCartney P, Duklas P, McEntegart M, Oldroyd KG, Greenwood JP, Muir D, Chowdhary S, Gershlick AH, Appleby C, Eteiba H, Cotton J, Wragg A, Curzen N, Tait RC, MacFarlane P, Welsh P, Sattar N, Petrie MC, Ford I, Fox KAA, McConnachie A, Berry C; T-TIME (Trial of low-dose adjunctive alTeplase during primary PCI) investigators. Effect of coronary flow on intracoronary alteplase: a prespecified analysis from a randomised trial. Heart. 2021 Jan 12:heartjnl-2020-317828. doi: 10.1136/heartjnl-2020-317828. Online ahead of print.
- Maznyczka AM, Oldroyd KG, Greenwood JP, McCartney PJ, Cotton J, Lindsay M, McEntegart M, Rocchiccioli JP, Good R, Robertson K, Eteiba H, Watkins S, Shaukat A, Petrie CJ, Murphy A, Petrie MC, Berry C. Comparative Significance of Invasive Measures of Microvascular Injury in Acute Myocardial Infarction. Circ Cardiovasc Interv. 2020 May;13(5):e008505. doi: 10.1161/CIRCINTERVENTIONS.119.008505. Epub 2020 May 15.
- McCartney PJ, Maznyczka AM, Eteiba H, McEntegart M, Oldroyd KG, Greenwood JP, Maredia N, Schmitt M, McCann GP, Fairbairn T, McAlindon E, Tait C, Welsh P, Sattar N, Orchard V, Corcoran D, Ford TJ, Radjenovic A, Ford I, McConnachie A, Berry C; T-TIME Investigators. Low-Dose Alteplase During Primary Percutaneous Coronary Intervention According to Ischemic Time. J Am Coll Cardiol. 2020 Mar 31;75(12):1406-1421. doi: 10.1016/j.jacc.2020.01.041.
- Maznyczka AM, Carrick D, Oldroyd KG, James-Rae G, McCartney P, Greenwood JP, Good R, McEntegart M, Eteiba H, Lindsay MM, Cotton JM, Petrie MC, Berry C. Thermodilution-derived temperature recovery time: a novel predictor of microvascular reperfusion and prognosis after myocardial infarction. EuroIntervention. 2021 Jun 25;17(3):220-228. doi: 10.4244/EIJ-D-19-00904.
- Maznyczka AM, McCartney PJ, Oldroyd KG, Lindsay M, McEntegart M, Eteiba H, Rocchiccioli P, Good R, Shaukat A, Robertson K, Kodoth V, Greenwood JP, Cotton JM, Hood S, Watkins S, Macfarlane PW, Kennedy J, Tait RC, Welsh P, Sattar N, Collison D, Gillespie L, McConnachie A, Berry C. Effects of Intracoronary Alteplase on Microvascular Function in Acute Myocardial Infarction. J Am Heart Assoc. 2020 Feb 4;9(3):e014066. doi: 10.1161/JAHA.119.014066. Epub 2020 Jan 28.
- McCartney PJ, Eteiba H, Maznyczka AM, McEntegart M, Greenwood JP, Muir DF, Chowdhary S, Gershlick AH, Appleby C, Cotton JM, Wragg A, Curzen N, Oldroyd KG, Lindsay M, Rocchiccioli JP, Shaukat A, Good R, Watkins S, Robertson K, Malkin C, Martin L, Gillespie L, Ford TJ, Petrie MC, Macfarlane PW, Tait RC, Welsh P, Sattar N, Weir RA, Fox KA, Ford I, McConnachie A, Berry C; T-TIME Group. Effect of Low-Dose Intracoronary Alteplase During Primary Percutaneous Coronary Intervention on Microvascular Obstruction in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial. JAMA. 2019 Jan 1;321(1):56-68. doi: 10.1001/jama.2018.19802.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alteplase | Protein / enzyme biologic | 10 mg | Other |
| Comparator | Alteplase | Protein / enzyme biologic | 20 mg | Other |