Low-Dose Aspirin for Primary

Prevention of Cardiovascular
Events in Patients with Type 2
Diabetes Mellitus
10-Year Follow-Up of a Randomized Controlled Tri
A)Are the results of the trial
valid?
1. Did the trial address a clearly focused issue:
.The population studied Japanese patients from 163
institutions throughout Japan with Type 2 Diabetes
Mellitus and without pre existing cardiovascular disease,
who were already recruited in JPAD trial
.The intervention given patients were to receive low-
dose aspirin therapy according to the decision of each
physician during the follow-up period
.The comparator given none
 The outcomes considered
The end points are divided into primary & secondary end
points.

The primary end points composed of:

Coronary causes : death from coronary causes, nonfatal
acute MI, unstable angina, newly developed exertional
angina
Cerebrovascular events: death from cerebrovascular causes,
nonfatal ischemic & hemorrhagic stroke, TIA
Vascular events: death from aortic causes, nonfatal aortic &
peripheral vascular disease
The secondary end points were as follows:
Coronary causes : death from coronary causes, nonfatal
acute MI, unstable angina, newly developed exertional
angina
Cerebrovascular events: death from cerebrovascular
causes, nonfatal ischemic & hemorrhagic stroke, TIA
Vascular events: death from aortic causes, nonfatal
aortic & peripheral vascular disease

DID THE TRIAL ADRESS A CLEARLY FOCUSED ISSUE?

YES
2. Was the assignment of patients to treatments randomized?
.How was this carried out? Was the allocation sequence concealed from researchers and
patients?
JPAD trial was a multicenter, randomized, standard care-controlled, open label, blinded end-end
point trial conducted in 163 institutions throughout Japan
Inclusion criteria:
.Type 2 DM
Age of 30-85years
.
Ability to provide informed consent
.
Exclusion criteria:
ECG changes ischemic ST segment depression, ST elevation, patho Q waves
.
H/O coronary artery disease by coronary angiography
.
H/O cerebrovascular disease infarction, hemorrhage, SAH or TIA
.
H/O peripheral atherosclerotic disease requiring tx
.
AF
.
Pregnancy
.
Use of antiplatelet or antithrombotic tx
.
H/O severe gastric or duodenal ulcer
.
Severe liver/ kidney dysf(x)
.
Allergy to aspirin
.
In JPAD trial, patients were randomly allocated (1:1) to receive aspirin or
no aspirin.
The randomization was performed as nonstratified randomization from a
random-number table.
Personnel at the central trial coordinating center prepared sealed
envelopes with random assignments & distributed to the physician in
charge at study sites by mail.
At the end of the trial, patients were administered low dose aspirin
according to the decision of each physician during the follow-up period
with the continuation of concurrent treatment.
The patients were checked whether they were administered low-dose
aspirin in the biennial follow-ups.

WAS THE ASSIGNMENT OF PATIENTS TO TREATMENTS RANDOMISED?

YES
3. Were all of the patients who entered the trial properly
accounted for at its conclusion?
.Was the trial stopped early?
No. In the JPAD trial, patient enrollment started in
December 2002 until May 2005. The JPAD trial completed
in April 2008 (median follow-up period was 4.4years). In
JPAD2, follow-up of the patients were done until July 2015
(median total follow-up duration was 10.3years).

.Were patients analysed in the groups to which they

were randomized?
Yes
Were all of the patients who entered the trial properly
accounted for at its conclusion?
Yes
4. Were patients, health workers and study personnel
blind to treatment?