Modest blood pressure reduction with valsartan in acute ischemic stroke: a prospective, randomized, open-label, blinded-end-point trial

Int J Stroke. 2015 Jul;10(5):745-51. doi: 10.1111/ijs.12446. Epub 2015 Jan 12.


Background and aims: To assess the efficacy and safety of modest blood pressure (BP) reduction with valsartan within 48 h after symptom onset in patients with acute ischemic stroke and high BP.

Methods: This was a multicenter, prospective, randomized, open-label, blinded-end-point trial. A total of 393 subjects were recruited at 28 centers and then randomly assigned in a 1:1 ratio to receive valsartan (n = 195) or no treatment (n = 198) for seven-days after presentation. The primary outcome was death or dependency, defined as a score of 3-6 on the modified Rankin Scale (mRS) at 90 days after symptom onset. Early neurological deterioration (END) within seven-days and 90-day major vascular events were also assessed.

Results: There were 372 patients who completed the 90-day follow-up. The valsartan group had 46 of 187 patients (24·6%) with a 90-day mRS 3-6, compared with 42 of 185 patients (22·6%) in the control group (odds ratio [OR], 1·11; 95% confidence interval [CI], 0·69-1·79; P = 0·667). The rate of major vascular events did not differ between groups (OR, 1·41; 95% CI, 0·44-4·49; P = 0·771). There was a significant increase of END in the valsartan group (OR, 2·43; 95% CI, 1·25-4·73; P = 0·008).

Conclusions: Early reduction of BP with valsartan did not reduce death or dependency and major vascular events at 90 days, but increased the risk of END.

Keywords: blood pressure; ischemic stroke; outcome.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Molecular Sequence Data
  • Nervous System Diseases / drug therapy
  • Nervous System Diseases / etiology
  • Outcome Assessment, Health Care
  • Prospective Studies
  • Stroke / complications
  • Stroke / drug therapy*
  • Valsartan / therapeutic use*


  • Angiotensin II Type 1 Receptor Blockers
  • Valsartan

Associated data

  • GENBANK/CD000039
  • GENBANK/CD002839