What are the inclusion criteria for the HOPE (Heart Outcomes Prevention Evaluation) stroke trial?

HOPE Trial Inclusion Criteria

The HOPE (Heart Outcomes Prevention Evaluation) trial enrolled patients aged ≥55 years who had established vascular disease OR diabetes mellitus plus at least one additional cardiovascular risk factor. 1

Primary Eligibility Requirements

Age Criterion

• Patients must be ≥55 years of age 1, 2, 3

High-Risk Cardiovascular Profile (Must Meet ONE of the Following)

Option 1: Established Vascular Disease

• History of coronary artery disease (CAD) 1, 2
• History of stroke or transient ischemic attack (TIA) - 11% of enrolled patients had prior stroke/TIA 1
• Peripheral vascular disease (PVD) 1, 2

Option 2: Diabetes Mellitus PLUS ≥1 Additional Risk Factor

• Diabetes mellitus (type 1 or type 2) was present in 36% of the total study population 2, 3
• Required at least one additional cardiovascular risk factor including: 1, 3
  • Known vascular disease
  • Cigarette smoking
  • Hypertension (present in nearly 50% at baseline) 3
  • High cholesterol 3

Key Baseline Characteristics

• Total enrollment: 9,541 participants across 267 sites in multiple countries 2
• Women comprised 27% of the study population 2
• Mean baseline blood pressure: 138/82 mm Hg - notably within "normal" range despite hypertension history 3, 4
• Concomitant medications permitted: antihypertensive drugs (excluding ACE inhibitors), lipid-lowering agents, and aspirin 3

Important Design Features

• 2x2 factorial design testing ramipril versus placebo AND vitamin E versus placebo 2, 3
• Ramipril dose: 10 mg daily (titrated up from lower doses) 3
• Planned follow-up: up to 4 years (stopped early at mean 5 years due to benefit) 1, 2, 3

Notable Exclusions (Implicit from Design)

• Patients already on ACE inhibitor therapy were excluded 3
• Patients with overt heart failure requiring ACE inhibitors were likely excluded based on standard of care 3
• No specific upper age limit was defined beyond the ≥55 year requirement 2