Adjunctive, Low-dose Intracoronary Recombinant Tissue Plasminogen Activator (tPA) Versus Placebo for Primary PCI in Patients With ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- MACE OR Myocardial Blush Grade 0/1 OR Distal Embolization OR Failure to Achieve ≥50% ST-segment Resolution
研究概览
简要总结
STRIVE will evaluate the use of adjunctive, low-dose intracoronary tissue plasminogen activator during primary percutaneous coronary intervention (PCI) for patients with ST elevation myocardial infarction (STEMI) in reducing the incidence of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.
详细描述
STRIVE is a prospective, 3-arm, parallel group, blinded, randomized controlled trial evaluating the efficacy of a novel approach to prevent and treat microvascular obstruction thereby reducing major cardiovascular events using intracoronary administration of very low-dose fibrinolytic (tissue plasminogen activator, tPA) directly into the culprit coronary artery during primary PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with STEMI undergoing primary PCI and,
- •ECG changes indicating large territory STEMI (defined as ≥2mm ST-segment elevation in 2 contiguous anterior precordial leads; or ≥2mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥8mm) and,
- •Randomization within 6 to 12 hours of symptom onset and,
- •Large thrombus burden with angiographic TIMI Thrombus Grade ≥3 after guidewire crossing.
排除标准
- •Active internal bleeding or high risk of bleeding or any prior intracranial bleeding.
- •Any other absolute or relative contraindication to fibrinolytic therapy.
- •Administration of a fibrinolytic ≤24hrs prior to randomization.
- •Cardiogenic shock on presentation.
- •Left bundle branch block (excluded because the ECG cannot be evaluated for ST segment resolution, an outcome of the study).
- •Planned upfront use of a glycoprotein IIb/IIIa inhibitor.
- •Any medical, geographic, or social factor making study participation impractical or precluding 1 month follow-up.
研究组 & 干预措施
Placebo
saline
干预措施: Saline (Other)
Intracoronary tPA 20 mg
干预措施: tissue plasminogen activator (Drug)
Intracoronary tPA 10 mg
干预措施: tissue plasminogen activator (Drug)
结局指标
主要结局
MACE OR Myocardial Blush Grade 0/1 OR Distal Embolization OR Failure to Achieve ≥50% ST-segment Resolution
时间窗: 30 days post-randomization
The primary efficacy variable is the binary composite outcome with the following components: * The occurrence of any of the MACE outcomes (cardiovascular death, myocardial re-infarction, cardiogenic shock and new onset heart failure) at 30 days post-randomization. * Post-procedural Myocardial Blush Grade of either 0 (Failure of dye to enter the microvasculature or persistent "staining", suggesting leakage of the contrast medium into the extravascular space) or 1 (Dye enters slowly but fails to exit the microvasculature. Dye is present in the next injection (30 seconds)). * Post-procedural Distal embolization, defined as distal filling defect with an abrupt 'cut-off' in one of the peripheral coronary branches of the infarct related artery, distal to the angioplasty site following PCI). * Failure to achieve ≥50% ST-segment resolution post-procedure.
次要结局
- Complete ST-segment Resolution.(30 minutes)
- CV Death, MI, Cardiogenic Shock or New Onset HF(30 Days)