PROTECT (Prospective Reinfarction Outcomes in the Thrombolytic Era Cardizem CD Trial): a randomized, double-blind clinical trial of diltiazem versus atenolol in secondary prophylaxis post non-Q wave myocardial infarction.
OBJECTIVE
To describe the rationale and design of the Prospective Reinfarction Outcomes in the Thrombolytic Era Cardizem CD Trial (PROTECT).


METHODS
A multicentre, randomized, double-blind, parallel-group comparison of once daily beta-therapy versus heart rate lowering calcium channel blocker therapy, in the reduction of one-year nonfatal reinfarction and cardiovascular death (combined primary end-point) initiated 24 to 96 h post non-Q wave myocardial infarction.


METHODS
One hundred and twenty hospitals across Canada.


METHODS
Over 7500 women and men aged 21 years or older with enzyme-confirmed non-Q wave infarction and without significant left ventricular systolic dysfunction will be recruited over two years.


METHODS
Once daily beta-blocker therapy (oral atenolol, 50 to 200 mg) versus once daily calcium channel blocker therapy (oral diltiazem 120 to 360 mg) with follow-up for up to three years.


CONCLUSIONS
The PROTECT will be the largest all-Canadian cardiovascular trial to date and will compare two commonly prescribed agents for secondary prophylaxis following non-Q wave infarction. The scientific question addressed by the PROTECT is of major public health importance and the results of the study will directly affect current clinical practice.
Goodman
S
S
St Michael's Hospital Clinical Trials Unit, University of Toronto, Ontario. goodmans@smh.toronto.on.ca
Hill
C
C
Bata
I
I
Fung
A
A
Higginson
L
L
Lam
J
J
Massel
D
D
McCans
J
J
Nasmith
J
J
Stanton
E
E
Thompson
C
C
Warnica
W
W
Langer
A
A
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D001262:Atenolol / Q000008:administration & dosage / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000627:therapeutic use*; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D004110:Diltiazem / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000517:prevention & control*; D012008:Recurrence
D000319:Adrenergic beta-Antagonists; D002121:Calcium Channel Blockers; D001262:Atenolol; D004110:Diltiazem