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Second Enhanced Control of Hypertension and Thrombectomy Stroke Study (ENCHANTED2)

2019-10-30 14:03:41 | BioPortfolio

Summary

ENCHANTED2 is an international, multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to assessf different approaches to blood pressure (BP) in acute ischemic stroke (AIS) patients who have undergone mechanical thrombectomy (MT). There are two nested substudies evaluating different approaches to secondary prevention in this high-risk stroke population.

Description

Objectives: To determine the effectiveness of more intensive BP lowering target (<120 mmHg) compared to higher BP management target (140-180mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to large vessel occlusion (LVO).

Inclusion Criteria:

1. Age ≥18 years;

2. Diagnosis of AIS with LVO confirmed by brain imaging;

3. Fulfill local criteria for MT therapy;

4. Achieve successful recanalization (TICI score ≥2b) after MT;

5. Provide written informed consent (or approved surrogate);

6. Persistent (2 readings <10 mins) systolic BP ≥140 mmHg <3 hours after recanalization;

7. No definite indication/contraindication to different intensities of BP lowering treatment;

Exclusion Criteria:

1. Unlikely to benefit from therapy (e.g. advanced dementia) or very high likelihood of early death post-MT, judged by responsible treating clinician.

2. Other medical illness that interferes with outcome assessments and follow-up (e.g. known significant pre-stroke disability (mRS scores 3-5), advance cancer and renal failure);

3. Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients);

4. Need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors.

5. Patients with aortic isthmus stenosis and arteriovenous shunt (exception: patients with haemodynamically inactive dialysis shunt).

6. Women who are lactating.

7. Currently participating in another trial which would interfere with outcome assessments.

Outcome Measures Primary outcome: functional recovery, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days.

Secondary outcomes: any intracranial haemorrhage (ICH), symptomatic intracerebral haemorrhage (sICH), early neurological deterioration, imaging assessment (e.g. infarct size, edema volume), death, disability, HRQoL, duration of hospitalization, residence; and health service use for calculation of resources and costs.

Randomisation and intervention: Randomisation is via a central internet-based system, stratified by site, time from symptom onset to recanalization (<6, ≥6 hours), baseline neurological impairment on the National Institutes for Health Stroke Scale (NIHSS, <17 vs ≥17), to ensure balance in key prognostic factors.

Intensive BP lowering group: to commence intravenous BP lowering therapy immediately after randomization, with systolic BP target (<120 mmHg) achieved within 30 minutes, and maintained for at least 72 hours (or hospital discharge if earlier).

Control group: to receive guideline-recommended BP control strategy to maintain BP level <180 mmHg after MT procedure, but BP lowering treatment given only for BP ≥150 mmHg to achieve target ≥140 mmHg.

Substudies: Patients enrolled in main study can also be randomised into 2 substudies according to separate eligibility criteria. Both are pilot studies embedded in main trial to recruit as many patients to inform sample size estimates for a further main study.

Substudy #1: Timing of anticoagulation Objective: To determine the effectiveness of early initiation of anticoagulation (at Day 4±2 of stroke onset) compared with late initiation (at Day 12±2) on a composite outcome of recurrent AIS, sICH, systemic embolism and/or vascular death within 90 days in patients with AF-related AIS due to LVO who receive MT. Randomisation (allocation 1:1 ratio) via same system as main study and stratified by site, NIHSS score at 24 hours (<10 vs ≥10) and anticoagulation intent (warfarin vs DOACs). Randomised patients will be allocated to either early group of initiating OAC therapy at Day 4±2 day of stroke onset, or late group of initiating OAC therapy at Day 12±2 of stroke onset. Primary outcome: composite of recurrent AIS, sICH, systemic embolism and/or vascular death within 90 days after randomisation.

Substudy #2: Duration of dual antiplatelet therapy (DAPT):

Objective: To determine the effectiveness of short duration of DAPT (<6 weeks) compared with standard duration (3 months or more) on recurrence rate within 12 months in patients with AIS due to large artery atherosclerosis (LAA) who are eligible for DAPT post-MT. Randomisation (allocation 1:1 ratio) will be done via the same system as the main study and stratified by site, and NIHSS score at 24 hours (<10 vs ≥10). Randomised patients will be allocated to either short duration group of receiving DAPT (aspirin 100 mg and clopidogrel 75 mg per day) for 6 weeks, or standard duration group receiving DAPT for 3 months. DAPT is started <48 hours post-randomization, and maintained changed to antiplatelet monotherapy (aspirin or clopidogrel) thereafter. Primary outcome is new stroke event (AIS or ICH) over 12 months.

Study Design

Conditions

Acute Ischemic Stroke

Intervention

Intensive BP lowering

Status

Not yet recruiting

Source

The George Institute for Global Health, China

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-30T14:03:41-0400

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Medical and Biotech [MESH] Definitions

The application of repeated, brief periods of vascular occlusion at the onset of REPERFUSION to reduce REPERFUSION INJURY that follows a prolonged ischemic event. The techniques are similar to ISCHEMIC PRECONDITIONING but the time of application is after the ischemic event instead of before.

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Ischemic injury to the OPTIC NERVE which usually affects the OPTIC DISK (optic neuropathy, anterior ischemic) and less frequently the retrobulbar portion of the nerve (optic neuropathy, posterior ischemic). The injury results from occlusion of arterial blood supply which may result from TEMPORAL ARTERITIS; ATHEROSCLEROSIS; COLLAGEN DISEASES; EMBOLISM; DIABETES MELLITUS; and other conditions. The disease primarily occurs in the sixth decade or later and presents with the sudden onset of painless and usually severe monocular visual loss. Anterior ischemic optic neuropathy also features optic disk edema with microhemorrhages. The optic disk appears normal in posterior ischemic optic neuropathy. (Glaser, Neuro-Ophthalmology, 2nd ed, p135)

The hospital unit in which patients with acute cardiac disorders receive intensive care.

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

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