A safety, efficacy trial evaluating the early administration of abciximab and reteplase combination treatment in PCI
This study is currently recruiting patients.
Sponsored by: |
Centocor |
Information provided by: |
Centocor |
Purpose
The purpose of this medical research study is to determine whether the administration of abciximab and reteplase before patients
have a coronary intervention, is safe and effective in the treatment of acute myocardial infarction compared to only abciximab
given during coronary intervention.
Condition
|
Treatment or Intervention |
Phase |
Myocardial Infarction
|
Drug: abciximab Drug: reteplase
|
Phase III
|
MedlinePlus related topics: Heart Attack
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Reteplase and Abciximab
with Abciximab Alone Administered Early or Just Prior to Primary Percutaneous Coronary Intervention (PCI) for Acute Myocardial
Infarction
Further Study Details:
Expected Total Enrollment:
3000
Study start: September 2002
Eligibility
Ages Eligible for Study:
21 Years and above,
Genders Eligible for Study:
Both
Inclusion Criteria:
- Be at least 21 years of age
- Have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of ischemia not eliminated with nitrates and onset
within 6 hours of randomization, and one of the following: a. ST-segment elevation greater than or equal to 2 mm in 2 (minimum
of 4 mm total in all leads) or more contiguous precordial ECG leads (anterior infarction) b. ST-segment depression greater
than or equal to 2 mm in V1, V2 or V2, V3 with reciprocal 1 mm ST-elevation in II, augmented unipolar foot (left leg) lead
(AVF), and V6 (true posterior infarction) c. ST-segment elevation greater than or equal to 1 mm in 2 or more contiguous limb
ECG leads (other infarction) d. New or presumably new left bundle branch block (LBBB)
Exclusion Criteria:
- Low risk clinical presentation, specifically have the combination of age < 60 years and local inferior infarction (ST-segment
elevation in only leads II, III, or AVF)
- Patients in whom the investigator anticipates that diagnostic angiography will occur within 60 minutes of qualifying ECG
- Patients in whom the investigator anticipates that PCI cannot occur within 4 hours of the qualifying ECG
- Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (eg, arrhythmia, severe
anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease or hypotension)
- Planned use of bivalirudin or other direct thrombin inhibitor during PCI
- Use of a fibrinolytic agent within 14 days prior to randomization
- Use of abciximab or any other GP IIb/IIIa inhibitor within 30 days prior to randomization
- Use of LMWH within 24 hours prior to randomization
- PCI within 7 days prior to randomization
- Suspected active internal bleeding or history of hemorrhagic diathesis
- Major surgery, biopsy of a parenchymal organ, eye surgery, or serious trauma within 6 weeks prior to randomization
- Gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance within 6 weeks prior to randomization
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the previous 2 years or any CVA with a
residual neurological deficit
- Administration of oral anticoagulants within 7 days prior to randomization unless prothrombin time (PT) less than or equal
to 1.2 times control (or international normalized ratio [INR] less than or equal to 1.4), or ongoing treatment with oral anticoagulants
- Known current platelet count less than 100,000 cells/uL
- Intracranial neoplasm, arteriovenous malformation, aneurysm, or aneurysm repair
- Confirmed hypertension with any repeated and reliable measurement of systolic blood pressure > 180 mmHg or diastolic blood
pressure > 100 mmHg at any time from presentation at the hospital to randomization
- Presumed or documented history of vasculitis
- Puncture of a non-compressible vessel within 24 hours prior to randomization
- Known allergy to abciximab or other murine proteins
- Known allergy to aspirin
- History of heparin allergy or heparin-induced thrombocytopenia or heparin-induced thrombosis
- Coexistent condition associated with a limited life expectancy (eg, advanced cancer)
- Participation in any phase of another clinical research study involving the evaluation of another investigational drug or
device within 30 days prior to randomization
- History or symptoms of aortic dissection
- Prolonged (greater than 20 minutes) or traumatic cardiopulmonary resuscitation (CPR) within 2 weeks prior to randomization
- Weight > 120 kg
- Known positive pregnancy test for women of childbearing age
- Patients receiving any UFH within 6 hours prior to randomization unless confirmation of an aPTT less than or equal to 70 seconds
is obtained prior to randomization
Location
and Contact
Information
Clinical Trial Information Line
1-877-736-5805
Ohio Cleveland Clinic Cardiovascular Coordinating Center, Cleveland,
Ohio,
44195,
United States; Recruiting
Clinical Trial Information Line
877-736-5805
More Information
American Heart Association
Act in Time to Heart Attach Signs
Study ID Numbers:
C0116T40; FINESSE
Record last reviewed:
January 2004
Record first received:
September 24, 2002
ClinicalTrials.gov Identifier:
NCT00046228Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10