Chronotherapy With Low-dose Aspirin for Primary Prevention "CARING"


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- Male or female subjects ≥ 50 years of age.
- Impaired fasting glucose (≥ 100 and < 126 mg/dl) in the last available blood test prior (≤ 3 months) to randomization, or diagnosis of type 2 diabetes prior to randomization.
- All subjects must have at randomization a conventional clinic systolic/diastolic BP < 160/100 mmHg.
- Informed consent to participate in the study prior to any study procedures.

Exclusion Criteria

- Known or suspected contraindications, including history of allergy to ASA.
- Uncontrolled essential hypertension of Grade 2-3, i.e., systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg before randomization.
- Evidence of a secondary form of hypertension, to include coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of hypertensive encephalopathy, cerebrovascular event, transient ischemic cerebral attack, or myocardial infarction prior to randomization.
- Type 1 diabetes mellitus.
- History of heart failure.
- Second or third degree heart block without a pacemaker.
- Concomitant unstable angina pectoris.
- Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia.
- Clinically significant valvular heart disease.
- Evidence of hepatic disease as determined by one of the following: ALT or AST values > 2 x UNL known before randomization, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt.
- Diagnosis of chronic kidney disease prior to randomization.
- History of malignancy including leukemia and lymphoma (but not basal cell skin cancer), or any other severe, life-threatening disease within the past five years.
- Any previous history of a systemic autoimmune disease.
- History of drug or alcohol abuse within the last two years.
- Use of any disallowed concomitant medication.
- Inability to communicate and comply with all study requirements.
- Persons directly involved in the execution of this protocol.