Adjunctive, Low-dose tPA in Primary PCI for STEMI

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.

• 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 of the summed absolute ST-segment deviations across associated and reciprocal leads at 30 minutes post-PCI

• 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).

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 of the summed absolute ST-segment deviations across associated and reciprocal leads at 30 minutes post-PCI.

Time to the first occurrence of MACE (composite of cardiovascular death, myocardial re-infarction, cardiogenic shock or new onset heart failure) over the duration of 30 days follow-up.

Clinically overt, bleeding with at least one of the following criteria:

• Fatal or
• Symptomatic intracranial hemorrhage or
• Retroperitoneal hemorrhage or
• Intraocular hemorrhage leading to significant vision loss or
• Decrease in hemoglobin of ≥ 3.0 g/dL (with each blood transfusion unit counting for 1.0 g/dL of hemoglobin or requiring transfusion of two or more units of red blood cells or equivalent of whole blood) or
• Requiring surgical intervention to stop the bleeding

Clinically overt, bleeding with at least one of the following criteria:

• Fatal or
• Symptomatic intracranial hemorrhage or
• Retroperitoneal hemorrhage or
• Intraocular hemorrhage leading to significant vision loss or
• Decrease in hemoglobin of ≥ 3.0 g/dL (with each blood transfusion unit counting for 1.0 g/dL of hemoglobin or requiring transfusion of two or more units of red blood cells or equivalent of whole blood) or
• Requiring surgical intervention to stop the bleeding Any other clinically significant bleeding not meeting the definition for major bleeding and resulting in hospital admission, prolonged hospital stay or transfusion of one unit of blood (whole blood or packed red blood cells (PRBC))

Failure to achieve ≥ 50% resolution of the ST-segment value (worst lead) at 30 minutes post-PCI

The composite of cardiovascular or non-cardiovascular death

Continuous measure of TIMI frame count as reported by Angiographic Core Lab.

Full perfusion of the infarct vessel with normal flow.

All deaths with a CV or unknown cause will be classified as CV. Only deaths due to a documented non-CV cause will be classified as non-CV.

At least one of the following:

• SBP <90mmHg and not responsive to fluid resuscitation and/or HR correction for at least 1 hr
• Need for vasopressor/inotropic therapy to maintain SBP >90mmHg for at least 1 hr, believed to be secondary to cardiac dysfunction and associated with Pulmonary edema/Hypoperfusion/Cardiac Index <2.0L/min New onset HF as per NYHA and defined as decision to treat with IV diuretic, inotropic agent or vasodilator with at least one of the following: presence of pulmonary edema or pulmonary vascular congestion on chest radiograph thought to be due to HF / râles reaching above the lower 1/3 of the lung fields thought to be due to HF / pulmonary capillary wedge pressure or left ventricular end-diastolic pressure = 18mmHg. In the case of new onset outpatient HF, re-admission to an acute care facility is required.