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Acute Myocardial InfarctionPhase 2ICE T-TIMI 49NCT00604695

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

A Phase 2 study testing Tenecteplase and Sterile Saline in people with Acute Myocardial Infarction, run by C. Michael Gibson, MS, MD at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Tenecteplase and Sterile Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
8 sitesUnited States
Study dates
Jul 2008to Nov 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 25Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Emory University

    Decatur, Georgia, 30033

  • Heart Consultants, PC

    Freemont, Nebraska, 68025

  • Northeast Georgia Heart Center, PC

    Gainesville, Florida, 30501

  • Crittenton Hospital Medical Center

    Rochester, Michigan, 48307

Other trials in United States

About this study

Official title: A Randomized Trial Evaluating Low-Dose IntraCoronary AdjunctivE Tenecteplase During Primary PCI for ST-Elevation Myocardial Infarction (ICE T)

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.

Read the detailed description

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 primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Efficacy will be assessed by measurements of both the angiographic characteristics of the culprit lesion as well as by measurements of epicardial flow and myocardial perfusion in the territory of the infarct-related artery. This study will also evaluate the safety of administering low-dose IC tenecteplase to subjects undergoing primary PCI for STEMI treated with standard therapy (aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors). Safety endpoints include the incidence of death, recurrent myocardial infarction (MI), abrupt vessel closure, subacute stent thrombosis, and TIMI major and minor bleeding events.

Prompt reperfusion therapy with primary PCI in patients with STEMI improves clinical outcomes through salvage of myocardial tissue. The proposed pilot trial is a randomized, placebo-controlled trial to evaluate the effectiveness and safety of adjunctive low-dose IC tenecteplase in conjunction with standard medical therapy during primary PCI for STEMI. We hypothesized that low-dose IC tenecteplase will enhance fibrinolysis at the site of the culprit lesion leading to reduced microvascular dysfunction. As reduced dose tenecteplase will be injected directly into the coronary artery increasing local concentration of the drug with minor systemic effects, an improved safety profile is also expected from this mode of administration.

Being tested
Tenecteplase, Sterile Saline
Keywords
ST-Elevation Myocardial Infarction, Acute Myocardial Infarction, No Reflow
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TenecteplaseDrug

    Intracoronary injection of IV tenecteplase.

  • Sterile SalineDrug

    Intracoronary injection of IV sterile saline

Study groups in NCT00604695
Study groupRoleWhat they receive
1Active comparatorTwo (4mg) doses of tenecteplase
Receives: Drug: Tenecteplase
2Placebo comparatorTwo (4mL) doses of sterile saline
Receives: Drug: Sterile Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (8)

  1. 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

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

  2. 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

    Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery

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

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

    Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery

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

  4. 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

    Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14

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

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

    Measured: Through 30days following PPCI

  6. Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding

    Measured: Through 30days following primary percutaneous coronary intervention

  7. Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias

    Measured: Through 30days following primary percutaneous coronary intervention

  8. Safety Endpoint: Number of Deaths

    Measured: Through 30days following primary percutaneous coronary intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00604695
Sponsor's protocol ID
N3770S
Acronym
ICE T-TIMI 49
Status last verified
Aug 2012
First submitted
7 Jan 2008
Last updated
7 Sep 2012
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31870492

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tenecteplase and Sterile Saline in people with Acute Myocardial Infarction, run by C. Michael Gibson, MS, MD at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention (time frame: Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604695, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.

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