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Table 1 Characteristics of clinical trials of aspirin therapy included in meta-analysis

From: Aspirin has potential benefits for primary prevention of cardiovascular outcomes in diabetes: updated literature-based and individual participant data meta-analyses of randomized controlled trials

Lead Author, publication date Name of study or source of participants Study design Patient population Location Baseline year of study Age group Males (%) Allocation concealment Blinding to subjects Blinding to carers Aspirin dose Medication compliance (%) Duration of therapy (years) Completeness of follow-up Trial participants with diabetes
Peto, 1988 BMD Randomised, open label with no placebo Healthy male doctors UK 1978–1979 19–90 100.0 No No No 500 mg daily NR 5.6 Unclear 101
PHS Steering Committee, 1989 PHS RCT, double blinded Healthy male doctors USA 1982 40–84 100.0 Unclear Yes Yes 325 mg every other day NR 5.0 99.7 533
ETDRS Investigators, 1992 ETDRS RCT, double blinded Participants with type 1 and 2 diabetes USA 1980–1985 18–70 56.5 Unclear Yes Yes 650 mg daily 91.8 5.0 94.7 3711
MRC, 1998 TPT Randomized, placebo controlled. Factorial with initial parallel group phase Patients at high risk for IHD UK 1989–1994 45–69 100.0 Adequate Yes Yes 75 mg daily NR 6.7 98.9 68
Hansson, 1998 HOT RCT, double blinded Participants with hypertension Multiple countries 1992–1994 50–80 NR Adequate Yes Yes 75 mg daily NR 3.8 97.4 1501
Sacco, 2003 PPP Randomised open trial with 2 × 2 factorial design Participants > 50 years with one or more CV risk factors Italy NR 64.3* 48.2 Adequate No No 100 mg daily 71.8 3.6 99.3 1031
Ridker, 2005 WHS RCT, double blinded, 2 x 2 factorial Healthy female health professionals USA 1993 ≥ 45 0.0 Unclear Yes Yes 100 mg on alternate days NR 10.1 99.4 1027
Belch, 2008 POPADAD RCT, double blinded, 2 x 2 factorial Patients ≥ 40 years with type 1 and 2 diabetes, ABP <=0.99 Scotland NR ≥ 40 44.1 Adequate Yes Yes 100 mg daily 50.0 6.7 99.5 1276
Ogawa, 2008 JPAD Randomised open label with blinded end point assessment Patients with type 2 diabetes Japan 2002 65.0* 55.0 Adequate No No 81 or 100 mg daily 90.0 4.4 92.4 2539
Ikeda, 2014 JPPP Randomised open label, parallel group Elderly with multiple atherosclerotic risk factors Japan 2005–2007 60–85 NR Adequate No No 100 mg daily 76.0 5.0 ~ 98.7 4903
McNeil, 2018 ASPREE RCT, double blind Community dwelling free of CVD, disability, dementia USA, Australia 2010–2014 ≥ 65 74.0 Adequate Yes Yes 100 mg daily 70.0 4.7 98.5 2057
ASCEND Study Group, 2018 ASCEND RCT, double blind Patients identified from diabetes registers or general practices UK 2005–2017 ≥ 40 63.0 Adequate Yes Yes 100 mg daily 70.0 7.4 99.1 15,480
  1. ASCEND, A Study of Cardiovascular Events in Diabetes; ASPREE, Aspirin to Reduce Risk of Initial Vascular Events; BMD, British male doctors; ETDRS, Early Treatment Diabetic Retinopathy Study; HOT, Hypertension Optimal Treatment; IHD, ischaemic heart disease; JPAD, Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes; JPPP, Japanese Primary Prevention Project; MRC, Medical Research Council; NR, not reported; PHS, Physicians’ Health Study; POPADAD, Prevention Of Progression of Arterial Disease And Diabetes; PPP, Primary Prevention Project; RCT, randomised controlled trial; UK, United Kingdom; USA, United States of America; WHS, Women’s Health Study
  2. * Average age