Incomplete infarction Trial of European Research Collaborators Evaluating Prognosis post-Thrombolysis [diltiazem] - INTERCEPT

Description:

Diltiazem for 6-month death, reinfarction and ischemia in uncomplicated MI.

Hypothesis:

Long-acting diltiazem 300mg QD + aspirin 160mg QD is superior to aspirin 160mg QD alone, when administered orally (within 36 to 96 hours) to patients with acute MI (enzyme/isoenzyme-confirmed) with neither congestive heart failure nor left-ventricular dysfunction.

Study Design

Study Design:

Patients Screened: to be determined
Mean Follow Up: To be determined
Mean Patient Age: to be determined
Female: to be determined

Patient Populations:

Men or women.
Age between 18 and 70 years.
First AMI suspected at hospital entry by a history of typical or atypical chest pain lasting at least 15 or 30 minutes with onset <12 hours before admission.
ECG detection of persistent ST-segment changes of >0.1 mV (1 mm equivalent), or T-wave inversion in >2 of 12 leads, or both.
Confirmation of AMI by elevation of total creatine kinase, or its MB isozyme (>2 times the upper limit of normal of the local laboratory range in >1 of the 2 samples drawn) within 30 hours of AMI (approximately 18 to 28 hours after completion of thrombolysis), or both.
Antecedent thrombolysis and aspirin within a 12-hour window from AMI onset.
Written informed consent.

Exclusions:

Age >70 years

Clinical history of AMI or existence of ECG Q-waves on the electrocardiogram

Left ventricular dysfunction detected by chest x-ray or clinical examination

History of chronic heart failure

At randomization:
enlarged heart (cardiothoracic index of >0.5)
bradycardia (<50 beats/minute)
sick sinus syndrome
atrioventricular block
rest angina

Before study entry:
recurrent ischemia following AMI
treatment with dihydropyridine calcium antagonists, diltiazem, verapamil, or bepridil within the week preceding study entry
use of antiarrhythmics, potassium channel blockers, cyclosporine, or treatment for arterial hypertension, unless treatment is stopped at study entry

Severe hypertension (i.e., blood pressure >210 mmHg systolic or >120 mmHg diastolic), or severe hypotension (systolic blood pressure <100 mmHg, or signs of hypoperfusion at randomization

Significant hypokalemia (<3.0 mmol/L or hyperkalemia (>5.5 mmol/L)

Suspected non-ischemic causes of acute chest pain (myocarditis, pericarditis, pulmonary embolism, rupture of aortic aneurysm)

Clinically significant cardiac, renal, hepatic, hematologic, thyroid, or peripheral/cerebral artery disease, or other important comorbidity likely to affect prognosis or outcome during the 6-month study period

Known hypersensitivity or allergy to diltiazem or aspirin

Pregnancy or lactating state (or those intending to become pregnant)

Use of any investigational drug within 30 days of randomization

Primary Endpoints:

Demonstrate the effect of the study drugs on the cumulative reduction in the combined event rate of cardiac mortality, recurrent nonfatal infarction, and medically refractory ischemia in post-AMI patients treated initially with thrombolytic therapy and followed for up to six months after random treatment assignment.

Drug/Procedures Used:

Diltiazem, 300mg qd plus aspirin, 160mg qd

Principal Findings:

Enrollment of 860 male and female patients (age 18 to 70 years) concluded in February 1997. Uniform six-month follow-up is currently in progress (as of August 1997). INTERCEPT is the first prospective, placebo-controlled trial of adjunctive calcium channel blocker therapy administered to MI patients who have first received streptokinase or t-PA. The purpose of this trial is to clarify the potential role of diltiazem secondary prevention in reducing long-term ischemic cardiac events in the post-thrombolysis era.

Interpretation:

Ongoing study

References:

1. Am J Cardiol 1995;75:1120-3. Trial design
2. Eur Heart J 1997;18(Abstr Suppl):172. Interim results

Clinical Topics: Dyslipidemia, Heart Failure and Cardiomyopathies, Lipid Metabolism, Acute Heart Failure

Keywords: Diltiazem, Myocardial Infarction, Isoenzymes, Ventricular Dysfunction, Creatine Kinase, Follow-Up Studies, Electrocardiography, Calcium Channel Blockers, Streptokinase, Chest Pain, Heart Failure, Tissue Plasminogen Activator, Informed Consent


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