ACCOMPLISH Trial

Trial Details:

Acronym: Avoiding Cardiovascular Events in COMbination Therapy in Patients LIving with Systolic Hypertension

Purpose: Evaluate the effect of amlodipine vs. hydrochlorothiazide in patients with hypertension and at high risk for cardiovascular disease.

Format: Multi-centered, double-blind, randomized, controlled trial

Treatment Group: Amlodipine plus benzapril

Control Group: Hydrochlorothiazide plus benzapril

Number of Patients: 11,506

Inclusion Criteria: Hypertension and high risk with age > 60 years old, systolic BP > 160 mmHg or currently on antihypertensive therapy and evidence of end organ damage (see below). Could be included if aged 55 to 59 years and meeting two or more criteria for end organ damage.

End organ damage defined as:

  • cardiac disease;
    • Prior myocardial infarction
    • Hospitalization for unstable angina
    • Previous coronary intervention
    • Left ventricular hypertrophy
  • previous stroke;
  • clinical peripheral arterial disease;
  • diabetes; and
  • chronic kidney disease (defined as Cr > 1.3 and/or macroalbuminuria).

Exclusion Criteria: 

  • recent angina (within 3 months of study entry);
  • prior systolic heart failure or EF < 40%;
  • recent myocardial infarction or acute coronary syndrome;
  • recent stroke or TIA (within 3 months of study entry);
  • refractory or secondary hypertension; and
  • other illness, physical impairment or mental condition that could interfere with effective conduct of the trial.

Primary Endpoint: Time to the composite of a cardiovascular event and death from cardiovascular cause.

Secondary Endpoints:

  • composite of cardiovascular events;
  • death from cardiovascular causes;
  • non-fatal stroke or MI;
  • hospitalization for heart failure; and
  • death from any cause.

Summary:

The ACCOMPLSH trial evaluated amlodipine (calcium channel blocker) vs. hydrochlorothiazide (diuretic) added to an ACE inhibitor (benzapril) in patients with hypertension and high cardiovascular disease risk. The composite primary endpoint of cardiovascular events and cardiovascular death was significantly reduced in the amlodipine arm compared with hydrochlorothiazide.

Original Publications:

Jamerson K, et al. N Engl J Med. 2008;doi:10.1056/NEJMoa0806182.

Weber MA, et al. Lancet, 2012;doi:10.1016/S0140-6736(12)61343-9.

Jamerson K, et al. N Engl J Med. 2010;doi:10.1056/NEJMc1001410.

Parra D, et al. N Engl J Med. 2009;doi:10.1056/NEJMc082725.