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Myocardial InfarctionPhase 2NCT00078013

MCC-135 as Adjunct Therapy to Primary Percutaneous Coronary Intervention in ST-Segment Elevation Acute Myocardial Infarction Patients

A Phase 2 study testing MCC-135 in people with Myocardial Infarction, run by Tanabe Pharma Corporation at 1 site 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

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary objectives of this study are to examine the safety, tolerability, and efficacy of intravenous MCC-135 in limiting final infarct size, as measured by single photon emission computed tomography (SPECT), in patients who… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
MCC-135
How many people
414 participants
Where
1 siteUnited States
Study dates
Apr 2003to Aug 2004
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent must be obtained from the patient (or, in accordance with state and federal laws and IRB regulations, emergency consent procedures may be employed) before enrollment into the study.
  • The patient is a male or female at least 18 years of age.
  • The patient has an estimated weight between 50 kg (110 lbs) and 140 kg (308 lbs).
  • The patient is suspected to have his/her first-documented ST-segment elevation AMI.
  • The patient has symptoms of ischemia of at least 20 minutes continuous duration, the onset of which occurred < 6 hours prior to study drug infusion. Examples of ischemic symptoms include chest, arm, and/or jaw pain, shortness of breath, nausea, diaphoresis, or other symptoms that the investigator considers to be of ischemic origin.
  • The patient has
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  • Anterior MI: > 2 mm ST elevation in at least two contiguous leads out of V1-V4
  • Inferior MI: > 2 mm ST elevation in at least two of II, III, and aVF, with > 10 mm elevation summed for all leads (14, 15)
  • Infero-apical MI: > 1 mm ST elevation in at least two of II, III, and aVF, with both V5 and V6
  • Infero-lateral MI: > 1 mm ST elevation in at least two of II, III, and aVF, with both I and aVL
  • Infero-posterior MI: > 1 mm ST elevation in II, III, and aVF, with > 1 mm ST depression in at least two leads out of V1-V3
  • The patient is expected to undergo primary PCI within 8 hours from the onset of ischemic symptoms (see Inclusion Criterion #5 above).
  • Women of childbearing potential must have a negative pregnancy test.

Who cannot join

  • The patient has a past history of ST-segment elevation MI.
  • The patient has a pathologic arrhythmia or is considered electrically unstable (K+, Ca2+).
  • The patient has thrombolytic therapy planned.
  • The patient is in cardiogenic shock unresponsive to IV fluid.
  • The patient has severe bradycardia with heart rate <45 beats/minute.
  • The patient has a pre-existing diagnosis of chronic heart failure (NYHA class III-IV).
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  • The patient has left bundle branch block.
  • The patient has any cardiomyopathy or pericarditis.
  • The patient has a history of clinically significant bleeding within the last 3 months.
  • The patient has had any type of major trauma, major surgery, or eye, spinal cord, or brain surgery within the last 3 months that, in the opinion of the investigator, would compromise the patient's response to the standard of care.
  • The patient has a history of clinically significant hepatic disturbance.
  • The patient has a history of chronic renal impairment.
  • The patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 6 months.
  • The patient is a woman who is pregnant or lactating.
  • The patient is currently receiving therapy with catecholamines/sympathomimetics, phosphodiesterase inhibitors, or phosphodiesterase inhibitors with calcium sensitizing activity. Patients will be permitted to enter the study if these drugs were discontinued more than 5 half-lives prior to randomization.
  • The patient has a history of multiple drug allergies (including contrast media).
  • The patient has epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child).
  • The patient participated in an investigational drug or device study within the last 3 months.
  • The patient has a current dependence on alcohol or history of other drugs of abuse.
  • The patient has current clinically significant psychiatric or neurologic disease or any other condition that, in the investigator's opinion, would prevent adherence to the requirements of the protocol.
  • The patient is clinically significantly immunocompromised (including, but not limited to AIDS and immune-suppressive therapy [i.e., chemotherapy, radiation, systemic corticosteroids]).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital/ Harvard Medical School

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Examine the Safety and Efficacy of Intravenous MCC-135 as an Adjunct to Standard Therapy With Primary PCI in Patients Diagnosed as Having an ST Elevation Acute Myocardial Infarction

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary objectives of this study are to examine the safety, tolerability, and efficacy of intravenous MCC-135 in limiting final infarct size, as measured by single photon emission computed tomography (SPECT), in patients who require percutaneous coronary intervention (PCI) for a first-documented ST-segment elevation acute myocardial infarction (AMI).

Read the detailed description

Patients will be male or female aged 18 years and older who present to the emergency room (ER) < 6 hours from onset of AMI symptoms. The AMI must be confirmed by a 12-lead electrocardiogram (ECG) and documented in at least 2 leads. Each potential patient must be a candidate for primary PCI and not have thrombolytic therapy planned. To be eligible, patients must not have a prior history of ST-segment elevation MI.

Patients will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups: A, B, and C. Group A will receive MCC-135 4.5 mg/kg/48 hours; Group B will receive MCC-135 9.0 mg/kg/48 hours; and Group C will receive placebo/48 hours. Three hundred thirty patients with a TIMI flow grade of 0/1 are required to complete the study. Because patients will be enrolled and will receive study medication prior to assessment of TIMI flow, it is expected that at least 414 patients may need to be randomized in order to obtain the required 330 qualified patients. All randomized patients will receive 48 hours of study medication, with ongoing assessments during this period, and will have follow-up assessments on Days 3, 4, 5, 30, and 180 as described below, regardless of preoperative TIMI flow grade.

Following initial physical examination, vital signs, establishment of a separate and dedicated IV access, baseline blood sampling, and confirmation of all study eligibility requirements, patients will be randomized and begin receiving study drug as an adjunct to standard therapy. Patients will begin study drug infusion as soon as possible, but < 6 hours following onset of AMI symptoms (i.e., symptoms of myocardial ischemia). Examples of ischemic symptoms include chest, arm, and/or jaw pain, shortness of breath, nausea, diaphoresis, or other symptoms that the investigator considers to be of ischemic origin. A negative result from a urine pregnancy test must be obtained for females of childbearing potential prior to the start of study drug infusion.

Being tested
MCC-135
Keywords
AMI, STEMI, Infarct, acute myocardial infarction with ST segment elevation
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction, Infarction

What participants receive

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

  • MCC-135Drug

Timeline

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

  1. First posted18 Feb 2004 (estimated)
  2. Study startApr 2003
  3. Study completionAug 2004

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
414 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00078013
Sponsor's protocol ID
MCC-135-A02
Status last verified
Mar 2005
First submitted
13 Feb 2004
Last updated
24 Jun 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MCC-135 in people with Myocardial Infarction, run by Tanabe Pharma Corporation at 1 site 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 13 inclusion and 21 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00078013.

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 24 Jun 2005.

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