Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II)
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Jacksonville, Florida: 12-009101
NCT ID: NCT01176565
Sponsor Protocol Number: ATTACH-II
About this study
The specific aims of this study are to:
- Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.
- Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months.
- Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of > 33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans.
- Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Age 18 years or older
- IV nicardipine can be initiated within 4.5 hours of symptom onset.
- Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
- Total GCS score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of ED arrival.
- INR value < 1.5
- CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc.
- For subjects randomized prior to IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization OR
- For subjects randomized after IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization.
- Informed consent obtained by subject, legally authorized representative, or next of kin.
- Note: Patients with SBP < 180mmHg should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the eligibility window closes.
- ICH is due to previously known neoplasms, AVM, or aneurysms.
- Intracerebral hematoma considered to be related to trauma.
- ICH located in infratentorial regions such as pons or cerebellum.
- IVH associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles.
- Patient to receive immediate surgical evacuation.
- Current pregnancy, or parturition within previous 30 days, or active lactation.
- Use of dabigatran within the last 48 hours.
- A platelet count less than 50,000mm3
- Known sensitivity to nicardipine.
- Pre-morbid disability requiring assistance in ambulation or activities of daily living.
- Subject's living will precludes aggressive ICU management.
- Subject is currently participating in another interventional clinical trial
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.