INTERACT2
Trial question
What is the role of intensive lowering of elevated BP in patients with intracerebral hemorrhage?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 2829
2829 patients (1049 female, 1780 male).
Inclusion criteria: patients who had had a spontaneous intracerebral hemorrhage within the previous 6 hours and who had elevated SBP.
Key exclusion criteria: structural cerebral cause for the intracerebral hemorrhage; deep coma; massive hematoma with a poor prognosis; planned early surgery to evacuate the hematoma.
Interventions
N=1399 intensive blood-pressure lowering (target systolic level < 140 mmHg within 1 hour).
N=1430 guideline-recommended BP lowering (target systolic level < 180 mmHg).
Primary outcome
Death or major disability at day 90
52%
55.6%
55.6 %
41.7 %
27.8 %
13.9 %
0.0 %
Intensive blood-pressure
lowering
Guideline-recommended blood pressure
lowering
No significant
difference ↔
No significant difference in death or major disability at day 90 (52% vs. 55.6%; OR 0.87, 95% CI 0.75 to 1.01).
Secondary outcomes
No significant difference in death (11.9% vs. 12%; OR 0.99, 99% CI 0.79 to 1.25).
No significant difference in problems with mobility (63.8% vs. 66.7%; OR 0.88, 95% CI 0.74 to 1.04).
Safety outcomes
No significant differences in nonfatal serious adverse events, neurologic deterioration in first 24 hours.
Conclusion
In patients who had had a spontaneous intracerebral hemorrhage within the previous 6 hours and who had elevated SBP, intensive blood-pressure lowering was not superior to guideline-recommended BP lowering with respect to death or major disability at day 90.
Reference
Craig S Anderson, Emma Heeley, Yining Huang et al. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65.
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