Intensive treatment of blood pressure in acute ischemic stroke. TICA 2 study.

INTERVENTION: Trade Name: Trandate 5 mg/ml solution for injection Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: LABETALOL HYDROCHLORIDE CAS Number: 32780‐64‐6 Trade Name: Elgadil 5mg/ml solution for infusion and injection Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: URAPIDIL CAS Number: 34661‐75‐1 Trade Name: NITROPRUSSIAT FIDES injectable Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: SODIUM NITROPRUSSIDE CAS Number: 13755‐38‐9 Trade Name: Urapidil Accord 5mg/ml solution for infusion and injection Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: URAPIDIL CAS Number: 34661‐75‐1 Trade Name: Trandate 5 mg/ml solution for injection Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: LABETALOL HYDROCHLORIDE CAS Number: 32780‐64‐6 Trade Name: Elgadil 5mg/ml solution for infusion and injection Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: URAPIDIL CAS Number: 34661‐75‐1 Trade Name: NITROPRUSSIAT FIDES injectable Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: SODIUM NITROPRUSSIDE CAS Number: 13755‐38‐9 Trade Name: Urapidil Accord 5mg/ml solution for infusion and injection Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: URAPIDIL CAS Number: 34661‐75‐1 CONDITION: Acute ischemic stroke ; MedDRA version: 19.0 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: Demonstrate that maintaining systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke is more effective than management by Guidelines recommendation (try when systolic blood pressure 185 mm Hg exceeding). Primary end point(s): Functional prognosis measured at 90 ± 15 days by modified Rankin scale. Secondary Objective: ‐ Demonstrate that the maintenance over 72 hours of systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke, determines a smaller percentage of early neurological deterioration, relative to conventional treatment according to international guidelines.; ‐ Demonstrate that the maintenance for 72 hours a systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke, reduces infarct volume (valued at neuroimaging at 24 hours) compared with conventional treatment according Guides international.; ‐ Demonstrate that the maintenance over 72 hours of systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke reduces mortality at 90 days measured relative to conventional management according to international guidelines.; ‐ Evaluate security between the two branches. Timepoint(s) of evaluation of this end point: 90 ± 15 days SECONDARY OUTCOME: Secondary end point(s): ‐ early neurological deterioration (DNP): Increased 4 or more points on the NIHSS scale in any determination within 72 hours compared with baseline score.; ‐ infarct volume: infarct volume in neuroimaging (CT or MRI) between 4th‐7th day after stroke is determined. the volume in mL is calculated using the formula a x b x c x 0.5, where "a" and "b" are the largest diameter perpendicular in centimeters and "c" the number of cuts of 1 cm in display infarction.; ‐ mortality: mortality shall be considered as any patient who dies from inclusion (signed informed consent) to the final study visit (90 ± 15 days); ‐ assessment of the safety of administering riboflavin in patients with clinical suspicion of stroke is performed by measuring adverse events throughout the study. Timepoint(s) of evaluation of this end point: ‐ Early neurological deterioration: within first72 hours.; ‐ Volume of infarction: between 4th‐7th day after the stroke.; ‐ Mortality: from inclusion to the final study visit (90 ± 15 days); ‐ Security: all visits. INCLUSION CRITERIA: • Men or women aged 18 and up to 85 years inclusive. • Diagnosis clinical and neuroimaging (CT or MRI) of ischemic stroke. • Ability to initiate antihypertensive treatment within 12 hours after the onset of symptoms (in the case of stroke, it is considered the start time as the time in which the patient has been asymptomatic last seen). • Participating with systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 220 mmHg at the time of inclusion. • Participant or able to understand the requirements of the study and sign the informed consent legal representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50