IC TITAN: A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00719914
• Collaborator: Schering-Plough (Industry)
• Enrollment: 31
• Locations: 3
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 10.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
ST-Elevation Myocardial Infarction	Drug: eptifibatide; Drug: eptifibatide; Drug: normal saline	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Intracoronary injection of eptifibatide	Drug: eptifibatide; Intra-coronary injection, weight based, of eptifibatide.; Drug: eptifibatide; Intra-coronary injection, based on weight, of eptifibatide
Placebo Comparator: 2 Intra-coronary injection of normal saline.	Drug: normal saline; Intra-coronary injection, weight based, of normal saline.

Outcome Measures

Primary Outcome Measures

1. 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) [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology Research Associates	Ormond Beach	Florida	United States	32174
2	Crittenton Hospital Medical Center	Rochester	Michigan	United States	48307
3	Mid Ohio Heart Clinic	Mansfield	Ohio	United States	44906

Sponsors and Collaborators

• Brigham and Women's Hospital
• Schering-Plough

Investigators

• Study Chair: Eugene Braunwald, M.D., TIMI Study Group
• Principal Investigator: C. Michael Gibson, M.D., TIMI Study Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C. Michael Gibson, MS, MD, Principal Investigator, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT00719914
• Other Study ID Numbers: T101
• First Posted: Jul 22, 2008
• Last Update Posted: Aug 27, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by C. Michael Gibson, MS, MD, Principal Investigator, Brigham and Women's Hospital: eptifibatide; Integrilin; ST-Elevation Myocardial Infarction; Acute Myocardial Infarction
• Additional relevant MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction; Eptifibatide

Study Results

Participant Flow

Arm/Group Title	Additional Bolus of Eptifibatide	Bolus of Normal Saline
Arm/Group Description	Intracoronary injection of eptifibatide	Intracoronary injection of normal saline.
Period Title: Overall Study
STARTED	10	7
COMPLETED	10	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Additional Bolus of Eptifibatide	Bolus of Normal Saline	Total
Arm/Group Description	Intracoronary injection of eptifibatide	Intra-coronary injection of normal saline.	Total of all reporting groups
Overall Participants	10	7	17
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.9 (10.2)	67 (9.5)	61.6 (10.7)
Age, Customized (participants) [Number]
<=18 years	0 0%	0 0%	0 0%
Between 18 and 75 years	9 90%	6 85.7%	15 88.2%
>=75 years	1 10%	1 14.3%	2 11.8%
Sex: Female, Male (Count of Participants)
Female	1 10%	0 0%	1 5.9%
Male	9 90%	7 100%	16 94.1%
Region of Enrollment (participants) [Number]
United States	10 100%	7 100%	17 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

study terminated due to low enrollment

Arm/Group Title	Additional Bolus of Eptifibatide	Bolus of Normal Saline
Arm/Group Description	Intracoronary injection of eptifibatide	Intra-coronary injection of normal saline.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Additional Bolus of Eptifibatide		Bolus of Normal Saline
Arm/Group Description	Intracoronary injection of eptifibatide		Intra-coronary injection of normal saline.
All Cause Mortality
	Additional Bolus of Eptifibatide		Bolus of Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Additional Bolus of Eptifibatide		Bolus of Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Additional Bolus of Eptifibatide		Bolus of Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Early termination due to poor enrollment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.