ST-Elevation Myocardial InfarctionPhase 2IC TITANNCT00719914
A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks
A Phase 2 study testing eptifibatide and normal saline in people with ST-Elevation Myocardial Infarction, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Elevation Myocardial Infarction
- What is being tested?
- eptifibatide and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2007to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical
- Patients (men or women) at least 18 years of age and
- Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction
- AND:
- ECG
- ST elevation >1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads
Who cannot join
- CLINICAL
- Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation
- Uncontrolled hypertension (SBP>180 OR DBP >110) at time of enrollment
- Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion
- Sinus bradycardia (HR <50/min), third degree or advanced second degree heart block.
- Known pregnancy
Show all 20Show fewer
- New or suspected new left bundle branch block
- BIOCHEMICAL
- Known thrombocytopenia (platelet count <100,000)
- Known severe renal insufficiency (creatinine >4.0 mg/dL)
- INCREASED BLEEDING RISK
- Active or recent (<1 year) bleeding or gastrointestinal hemorrhage
- Major surgery <1 month
- Known coagulopathy, platelet disorder or history of thrombocytopenia: If a patient is known to be on chronic warfarin therapy, the International Normalized Ratio (INR) must be known to be <1.6 in order for the patient to be included
- Known neoplasm
- Any history of hemorrhagic cerebrovascular disorder or active intracranial pathology
- MEDICATIONS
- Administration of a fibrinolytic agent within 7 days
- Known allergy or contraindication to eptifibatide OR aspirin OR heparin
- Treatment with another GP IIb/IIIa inhibitor within 7 days
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mid Ohio Heart Clinic
Mansfield, Ohio, 44906
Cardiology Research Associates
Ormond Beach, Florida, 32174
Crittenton Hospital Medical Center
Rochester, Michigan, 48307
About this study
Official title: IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial
The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. This new way of giving the drug is being studying.
Read the detailed description
The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection of placebo (saline). The primary endpoint chosen to evaluate this hypothesis is the improvement in percent diameter stenosis of the culprit artery following the IC bolus administration of eptifibatide vs. IC placebo (saline) as assessed with quantitative coronary angiography (QCA).
- Conditions
- ST-Elevation Myocardial Infarction
- Being tested
- eptifibatide, normal saline
- Keywords
- eptifibatide, Integrilin, ST-Elevation Myocardial Infarction, Acute Myocardial Infarction
- 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.
eptifibatideDrug
Intra-coronary injection, weight based, of eptifibatide.
eptifibatideDrug
Intra-coronary injection, based on weight, of eptifibatide
normal salineDrug
Intra-coronary injection, weight based, of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intracoronary injection of eptifibatide Receives: Drug: eptifibatide |
| 2 | Placebo comparator | Intra-coronary injection of normal saline. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2008
- Study completionJan 2009
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ST-Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Principal investigator, C. Michael Gibson, MS, MD, Brigham and Women's Hospital
- Investigators
- Eugene Braunwald, M.D., Study chair, The TIMI Study GroupC. Michael Gibson, M.D., Principal investigator, The TIMI Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719914
- Sponsor's protocol ID
- T101
- Acronym
- IC TITAN
- Status last verified
- Jul 2012
- First submitted
- 7 Jan 2008
- Last updated
- 27 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial
- ClinicalTrials.gov ID
- NCT00719914
- Acronym / sponsor ID
- IC TITAN / T101
- Conditions
- ST-Elevation Myocardial Infarction
- Keywords
- eptifibatide, Integrilin, ST-Elevation Myocardial Infarction, Acute Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Posted 27 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. This new way of giving the drug is being studying.
Detailed description
The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection of placebo (saline). The primary endpoint chosen to evaluate this hypothesis is the improvement in percent diameter stenosis of the culprit artery following the IC bolus administration of eptifibatide vs. IC placebo (saline) as assessed with quantitative coronary angiography (QCA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: eptifibatideIntracoronary injection of eptifibatide |
| 2 | Placebo comparator | Drug: normal salineIntra-coronary injection of normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical
- Patients (men or women) at least 18 years of age and
- Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction
- ECG
- ST elevation >1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads
Key exclusion criteria (20 listed)
- CLINICAL
- Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation
- Uncontrolled hypertension (SBP>180 OR DBP >110) at time of enrollment
- Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion
- Sinus bradycardia (HR <50/min), third degree or advanced second degree heart block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eptifibatideIntra-coronary injection, weight based, of eptifibatide. | Drug | 1 |
| eptifibatideIntra-coronary injection, based on weight, of eptifibatide | Drug | 1 |
| normal salineIntra-coronary injection, weight based, of normal saline. | Drug | 2 |
Primary outcome
Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Braunwald, M.D. study chair
The TIMI Study Group
C. Michael Gibson, M.D. principal investigator
The TIMI Study Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eptifibatide and normal saline in people with ST-Elevation Myocardial Infarction, run by Brigham and Women's Hospital at 3 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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 27 Aug 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?
Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2012.