A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: Tenecteplase; Sterile Saline
Intervention description: Intracoronary injection of IV tenecteplase.; Intracoronary injection of IV sterile saline
Intervention MeSH terms: Tenecteplase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: ST-Elevation Myocardial Infarction; Acute Myocardial Infarction; No Reflow

Summary:

      The primary objective of this study is to gather preliminary data regarding the angiographic
      efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during
      balloon angioplasty for heart attacks.

      We hypothesize that low-dose IC tenecteplase will enhance the breakdown of blood clots at the
      site of the culprit lesion leading to reduced damage to the heart muscle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects (men or women) at least 18 years and less than 75 years of age and

          -  Ischemic discomfort ≥20 minutes and ≤6 hours of duration and

          -  ST elevation ≥1mm (≥0.1mV) in two contiguous limb leads OR ≥2mm (≥0.2mV) in two
             contiguous precordial leads and

          -  Occluded infarct-related artery (TIMI Flow Grade 0 or 1) at the time of coronary
             angiography and

          -  Planned primary PCI within 2 hours of hospital presentation and

          -  Planned or concomitant use of aspirin, clopidogrel, unfractionated heparin, and
             Glycoprotein IIb/IIIa inhibition with intent to stent the infarct-related artery and

          -  Informed consent able to be obtained

        Exclusion Criteria:

        CLINICAL

          -  Age ≥75 years

          -  Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor
             resuscitation.

          -  Uncontrolled hypertension (SBP >180 OR DBP >110) at time of enrollment.

          -  Cardiac arrest or arrhythmia requiring chest compressions or cardiopulmonary
             resuscitation.

          -  Known pregnancy.

        BIOCHEMICAL

          -  Known thrombocytopenia (platelet count <100,000)

          -  Known severe renal insufficiency (creatinine >4.0 mg/dL).

        INCREASED BLEEDING RISK

          -  Active internal bleeding

          -  Recent (<3 months) gastrointestinal hemorrhage

          -  Recent intracranial or intraspinal surgery, trauma, major surgery, or biopsy of a
             parenchymal organ (< 1 month)

          -  Known coagulopathy, platelet disorder, or history of thrombocytopenia

          -  Current warfarin therapy

          -  Known neoplasm

          -  Any known history of transient ischemic attack, cerebrovascular accident, or active
             intracranial pathology including arteriovenous malformation or aneurysm

        MEDICATIONS

          -  Administration of a fibrinolytic agent within 72 hours

          -  Known allergy or contraindication to fibrinolytics OR aspirin OR heparin OR
             clopidogrel

        ANGIOGRAPHIC

          -  Left Main Coronary artery culprit lesion

          -  Ostial culprit lesion (ostium of LAD, LCX, or RCA).

          -  Lesion in non-native coronary artery (e.g. saphenous vein graft, arterial conduit
             graft)

          -  Subjects requiring urgent coronary artery bypass grafting