Phase 2 N=40 Randomized Treatment

A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks

Acute Myocardial Infarction

Bottom Line

View on ClinicalTrials.gov: NCT00604695 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

Sep 2012

Primary outcome: Primary: Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention — 100; 100 Percent diameter stenosis

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Tenecteplase (Drug); Sterile Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: C. Michael Gibson, MS, MD
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention	100; 100	—
SECONDARY Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention	7; 2	—
SECONDARY Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug	8; 8	—
SECONDARY Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)	26; 14	—
SECONDARY Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14	1; 5	—
SECONDARY Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding	1; 0	—
SECONDARY Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding	4; 2	—
SECONDARY Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias	1; 2	—
SECONDARY Safety Endpoint: Number of Deaths	1; 0	—

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 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00604695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.