ACCOMPLISH Trial

By Steven Lome 

Trial categories: Hypertension

Summary:

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

Original Publications:

N Engl J Med. 2008 Dec4;359(23):2417-28.

Lancet, 2012 Dec 5. pii:S0140-6736(12)61343-9.

N Engl J Med. 2010 July1;363:98

N Engl J Med. 2009 March12;360:1147-1150

Trial Details:

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

Purpose: Evaluate the effect of amlodipine versus hydrochlorothiazide in patients with hypertension and high risk of cardiovascular disease

Format: Multi-centered double blind randomized controlled trial

Treatment Group: Amlodipine + benzapril

Control Group: Hydrochlorothiazide + benzapril

Number of Patients: 11,506

Inclusion Criteria: Hypertension and high risk with age > 60 years old, systolic blood pressure > 160 mmHg or currently on antihypertensive therapy AND evidence of end organ damage (see below). If age 55-59 could be included if two or more criteria for end organ damage met. 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 mellitus
  • 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
  • Other illness, physical impairment or mental condition that could interfere with effective conduct of the trial

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

Secondary Endpoint(s):

  • Composite of cardiovascular events
  • Death from cardiovascular causes
  • Non-fatal stroke or MI
  • Hospitalization for heart failure
  • Death from any cause.

Related Links:

Calcium Channel Blockers - Review

ACE inhibitors - Review