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

NCT00604695 | Completed Phase 2 Results DMC

• 1 other identifier: N3770S
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Acute Myocardial Infarction

Keywords

ST-Elevation Myocardial Infarction; Acute Myocardial Infarction; No Reflow

Outcome Measures

Primary Outcomes (1)

• Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention

  Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention

Secondary Outcomes (8)

• 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

  Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention

• 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

  Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug

• Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)

  Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug

• 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

  Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug

• Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding

  Through 30days following PPCI

Study Arms (2)

1

ACTIVE COMPARATOR

Two (4mg) doses of tenecteplase

Drug: Tenecteplase

2

PLACEBO COMPARATOR

Two (4mL) doses of sterile saline

Drug: Sterile Saline

Interventions

Tenecteplase DRUG

Intracoronary injection of IV tenecteplase.

1

Sterile Saline DRUG

Intracoronary injection of IV sterile saline

2

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C. Michael Gibson, MS, MD: lead
• Genentech, Inc.: collaborator

Study Sites (8)

Northeast Georgia Heart Center, PC

Gainesville, Florida, 30501, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Emory University

Decatur, Georgia, 30033, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Crittenton Hospital Medical Center

Rochester, Michigan, 48307, United States

Location

Heart Consultants, PC

Freemont, Nebraska, 68025, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Gibson CM, Kumar V, Gopalakrishnan L, Singh P, Guo J, Kazziha S, Devireddy C, Pinto D, Marshall JJ, Stouffer GA, Mavromatis K, Grip L, Bainey KR; TIMI & PERFUSE Study Group. Feasibility and Safety of Low-Dose Intra-Coronary Tenecteplase During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (ICE T-TIMI 49). Am J Cardiol. 2020 Feb 15;125(4):485-490. doi: 10.1016/j.amjcard.2019.11.018. Epub 2019 Nov 20.

  PMID: 31870492 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This pilot study was not adequately powered to exclude a modest increase in bleeding events. Study drug could not be administered to 4 patients and 7 patients were excluded for not meeting the inclusion criteria of TIMI Flow Grade 0/1 at enrollment.

Results Point of Contact

• Title: C. Michael Gibson, MS, MD
• Organization: Brigham & Women's Hospital

mgibson@perfuse.org

617-632-7753

Study Officials

• C. Michael Gibson, MS, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 30, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 7, 2012
• Results First Posted: September 7, 2012

Record last verified: 2012-08

Locations

US (8)