Status:
ACTIVE_NOT_RECRUITING
Chronotherapy with Low-dose Aspirin for Primary Prevention
Lead Sponsor:
University of Vigo
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Brief summary: Aspirin (ASA) has been shown to provide marked benefits in primary and secondary prevention of cardiovascular events. Substantial evidence suggests that low-dose ASA therapy should als...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
3200 Patients enrolled
Trial Details
Trial ID
NCT00725127
Start Date
October 1 2008
End Date
June 30 2026
Last Update
December 6 2024
Active Locations (19)
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1
CS Friol
Friol, Lugo, Spain, 27220
2
CS Fingoi
Lugo, Lugo, Spain, 27002
3
Complexo Hospitalario Universitario de Ourense
Ourense, Orense, Spain, 32005
4
CS A Estrada
A Estrada, Pontevedra, Spain, 26680