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ATACH-II: Nicardipine for Acute Intracerebral Hemorrhage
NCT01176565Phase 3
Key facts
- Status
- Terminated
- Start
- May 2011
- Primary completion
- Dec 2015
- Countries
- 7
- Sponsor
- University of Minnesota
- Modality
- Small Molecules
- Drugs
- nicardipine
- Conditions
- intracerebral hemorrhage (ICH)
01
Overview
Phase 3, randomised, open-label trial of nicardipine in intracerebral hemorrhage (ICH) (2 arms), sponsored by University of Minnesota. Primary endpoint: Death or Disability According to Modified Rankin Scale Score at 3 months. Started May 2011; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard SBP Reduction
Target SBP < 180 mmHg
Intensive SBP Reduction
Target SBP < 140 mmHg
03
Who it enrols
Adult patients with spontaneous supratentorial intracerebral hemorrhage treated within 4.5 hours of onset, with SBP > 180 mmHg and GCS >= 5.
04
Endpoints
Primary
Death or Disability According to Modified Rankin Scale Score
Secondary
Quality of Life Using EuroQol Measures
Proportion of Hematoma Expansion
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