Please select the eligibility criteria that correspond to the clinical trial below.
Title: Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Brief Summary: Multicenter, prospective, randomised, open study comparing the effect of the following two strategies in hypertensive subjects \> 55 years and poorly controlled (systolic blood pressure \>= 150 mmHg) by antihypertensive treatment:

* usual strategy: reduction of systolic blood pressure to below 140 mmHg, independently of diastolic blood pressure levels;
* intensive strategy: reduction of systolic blood pressure to below 130 mmHg, independently of diastolic blood pressure levels.

During the initial run in period two qualifying visits at distance of 7-14 days will be carried out to establish whether blood pressure remains uncontrolled (systolic blood pressure \>=150 mmHg)by current drug treatment. At the end of the second visit eligible patients will be admitted to the study and the following examinations will be carried out: clinical visit, routine laboratory tests, 12-lead ECG. At this point eligible patients will be randomised to one of the two blood pressure goals outlined above.

Subsequent clinical visits will be carried out at 4 month-intervals up to the end of the study (4, 8, 12, 16, 20, 24 months).


Options:
A: Inclusion 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 Glasgow Coma Scale (GCS) score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of emergency department (ED) arrival.
* International normalized ratio (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.

  * Notes: The unit "mmHg" stands for "millimeters of mercury", a standard way of measuring blood pressure. Patients with SBP \< 180 mmHg should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the eligibility window closes.

Exclusion Criteria:

* ICH is due to previously known neoplasms, arteriovenous malformation (AVM), or aneurysms.
* Intracerebral hematoma considered to be related to trauma.
* ICH located in infratentorial regions such as pons or cerebellum.
* Intraventricular hemorrhage (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 50,000 per microliter (µL or mm3)
* 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

  * Use of dabigatran was clarified through investigator presentations, educational materials, and clinical tools to include newer similar class medications (such as rivaroxaban, apixaban, and edoxaban) that were being developed and in various stages of approval across enrolling countries through the course of this trial, in the event that patients using these medications may have been encountered during screening.
B: Inclusion Criteria:

* written informed consent to the study
* age \>= 55 years at randomization. There is no upper age limit
* systolic blood pressure \>= 150 mmHg in 2 visits at distance of 7-14 days, irrespective of diastolic pressure. Duration of treatment before visit 1 must be at least 12 weeks
* at least one additional risk factor including the following:
* current cigarette smoking
* total cholesterol \>= 20 mmg/dl, or High Density Lipoproteins (HDL) \< 40 mg/dl, or Low Density Lipoproteins (LDL) cholesterol \>= 130 mg/dl
* family history of cardiovascular disease in male first degree relative \< 55 years or female first degree relative \< 65 years
* previous TIA or stroke
* previous coronary artery disease
* history of peripheral occlusive arterial disease (claudication intermittens associated with angiographic or echographic evidence of \> 60% stenosis)

Exclusion Criteria:

* diabetes (fasting glucose \> 125 mg/dl in two samples or ongoing diabetic treatment)
* renal failure, defined by a serum creatinine \> 2.0 mg/dl
* chronic atrial fibrillation or flutter
* clinically significant hepatic or hematological disorders, alcoholism, drug addiction
* causes precluding ECG interpretation for LVH: complete right or left bundle block, Wolff-Parkinson-White syndrome, previous Q-wave myocardial infarction
* any disease causing reduced life expectancy
* unwilling to participate
* significant (more than traces of) valvular heart disease
C: Inclusion Criteria:

1. At least ≥50 years old, and
2. Systolic blood pressure (SBP): (having documentation of SBP to meet the criteria below on 2 consecutive visits)

   * SBP: 130-180 mmHg on 0 or 1 medication
   * SBP: 130-170 mmHg on up to 2 medications
   * SBP: 130-160 mmHg on up to 3 medications
   * SBP: 130-150 mmHg on up to 4 medications, and
3. Prior vascular disease or at high vascular risk

   1. Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), at least a 50% diameter stenosis of a coronary, chest pain with objective evidence of myocardial ischemia (load electrocardiogram or load image examination indicated myocardial ischemia)
   2. Previous stroke
   3. Carotid endarterectomy (CE), or carotid stenting
   4. Peripheral artery disease (PAD) with revascularization
   5. Abdominal aortic aneurysm (AAA) ≥5 cm with repair
   6. Combine with no less than two risk factors below

      * ≥60 years old male or ≥65 years old female
      * Diabetes
      * Dyslipidemia (total cholesterol \>200 mg/dL \[5.2 mmol/L\] or LDL-C \>130 mg/dL \[3.4 mmol/L\] or HDL-C \< 40 mg/dL \[1.0 mmol/L\])
      * Current smoking (smoke more than a cigarette every day in the past 12 months)

Exclusion Criteria:

1. Known secondary cause of hypertension
2. An indication for a specific BP lowering medication that the participant is not taking and the participant has not been documented to be intolerant of the medication class
3. One minute standing SBP \<110 mmHg (not applicable if unable to stand)
4. Arm circumference too large or small to allow accurate blood pressure measurement with available devices
5. Proteinuria defined as urine dipstick ≥2+ protein at screening
6. Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
7. eGFR \<45 ml/min /1.73m2 or end-stage renal disease (ESRD)
8. Previous MI, stroke, or hospitalization for angina, PCI, CABG, CE or carotid stenting, PAD with revascularization, AAA≥5 cm with repair within last 3 months
9. Symptomatic heart failure within the past 6 months or documented left ventricular ejection fraction (by any method) \<35%
10. PCI or CABG planned for the next 6 months
11. A medical condition likely to limit survival to less than 3 years, or a cancer (other than non-melanoma skin cancer) diagnosed and treated within the past two years that, in the judgment of local clinical investigators, would compromise a participant's ability to comply with the protocol and complete the trial
12. Any organ transplant
13. Pregnancy, breast-feeding, or of child-bearing potential and not using adequate contraception
14. Any factors judged by local clinic investigators to be likely to limit adherence to interventions. For example,

    1. Active alcohol or substance abuse within the last 12 months
    2. Plans to move to another place to live for a long time
    3. Clinical diagnosis of dementia or mild cognitive impairment (MCI)
15. Currently participation in a clinical trial with an unlicensed drug or device
16. Living in the same household as an already randomized participant
D: Inclusion Criteria:

* as above

Exclusion Criteria:

* patients with a history of ischaemic heart disease, heart failure, cerebrovascular disease, peripheral arterial disease or congenital coronary anomalies, prior to entry into the cohort
* patients with symptoms of chest pain in the 6 months prior to cohort entry
* patients \< 35 or \>100 years of age after eligibility for entry to the cohort

Answer: B