Proc Contents, Freq, and Means output in MS Word.
The Sibrafiban Versus Aspirin to Yield Maximum Protection from Ischemic Heart Events Post Acute Coronary Syndromes (SYMPHONY) study was a randomized trial designed to compare aspirin and sibrafiban in patients with acute coronary syndromes.A total of 9233 patients were randomized to either aspirin or low-dose sibrafiban or high-dose sibrafiban. The primary objective of the study was to determine whether sibrafiban reduced the 90-day rate of a composite endpoint that included death. The test of the primary study hypothesis did not result in statistical significance although the data suggested a possible increase in bleeding complications related to the higher-dose of sibrafiban. Subsequently, several DCRI papers have used these data to examine issues related to the optimal timing of treatment initiation.
Primary clinical paper:
Comparison of sibrafiban with aspirin for prevention of cardiovascular events after acute coronary syndromes: a randomized trial. The SYMPHONY Investigators. Sibrafiban versus Aspirin to Yield Maximum Protection from Ischemic Heart Events Post-acute Coronary Syndromes. Lancet 2000 Jan 19; 355(9201): 337-345.
Study design reference:
Newby LK. Long-term oral platelet glycoprotein IIb/IIIa receptor antagonist with sibrafiban after acute coronary syndromes: study design of sibrafiban versus aspirin to yield maximum protection from ischemic heart events post-acute coronary syndromes (SYMPHONY) trial. Symphony Steering Committee. American Heart Journal 1999; 138: 210-218.
Observational studies using SYMPHONY data:
Newby LK, Kristinsson A, Bhapkar MV, Aylward PE, Dimas AP, Klein WW, McGuire DK, Moliterno DJ, Verheugt FW, Weaver WD, Califf RM. SYMPHONY and 2nd SYMPHONY Investigators. Sibrafiban vs aspirin to yield maximum protection from ischemic heart events post-acute coronary syndromes. Journal of the American Medical Association 2002; 287: 3130-3132.
Data Dictionary for s1s2.sas7bdat
extract from Symphony / 2nd Symphony database. N=1500
Variable name format Values Definition
dummyid N 1-1500 Dummy patient ID number
trial n 1,2 1=Symphony, 2=2nd Symphony
Age n 28-96 Age in years
Sex c M, F F=female, M=male
Creat N 7-133 Baseline serum creatinine (umol/L)
Region C AUNZ, Asia, EE, LA, NA, WE AUNZ=Australia / New Zealand
Asia= Asia, EE=Eastern Europe, LA=Latin America
NA=North America, WE=Western Europe
Qemii N 0,1 0= Unstable Angina as Qualifying event
1= Myocardial Infarction as Qualifying event
Qekillip N 1-4 Killip Class at Qualifying Event
Qedbp N 30-150 Diastolic Blood Pressure at Qualifying Event
Qesbp N 60-256 Systolic Blood Pressure at Qualifying Event
Randhr N 40-122 Heart rate at Randomization
Qechf N 0,1 Congestive Heart Failure between Qualifying Event and Randomization
Hxhtn N 0,1 History of Hypertension
Hxmi N 0,1 Prior Myocardial Infarction before Qualifying Event
Baceinhb N 0,1 ACE inhibitors used prior to randomization
Bdiuretc N 0,1 Diuretics used prior to randomization
Prepci N 0,1 PCI prior to randomization
Death90 N 0,1 Death within 90 days after randomization
Dthdays N 0-88 Days to Death
Survdays N 0-90 Maximum known survival days (censored at 90)
Cecmi90 N 0,1 Myocardial infarction within 90 days after randomization
Midays N 0-87 Days to MI
Comp290 N 0,1 Death or MI within 90 days after randomization
C2days N 0-88 Days to Death or MI