A clinical trial to evaluate combination of 4 cardiovascular drugs and aspirin and Vitamin D supplementation in subjects for cardiovascular diseases

Phase 3

Active, not recruiting

• Conditions: Health Condition 1: null- Hypertension, diabetes mellitus, hypercholesterolemia

• Registration Number: CTRI/2012/11/003108
• Lead Sponsor: Cadila Pharmaceutical Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Men aged >= 50 years and women aged >= 55 years, with an INTERHEART risk score of 10 or greater; OR Men or women aged >= 65 years, with an INTERHEART risk score of 5 or greater

2. Provision of informed consent

Exclusion Criteria

1. Participant with a clear indication, contraindication, preference for or intolerance to statin, beta blocker (eg. bradycardia), ACE inhibitor, diuretic, aspirin or clopidogerel in the judgment of the physician.

2. Regular use of vitamin D at dos higher than 400 IU per day.

3.Hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication or indication for vitamin D therapy.

4.Peptic ulcer disease, frequent dyspepsia or bleeding.

5.Known vascular disease. (eg. Stroke, TIA, Angina, MI, ACS, PVD including claudication and amputation).

6.Mean systolic BP below 120 mm Hg at run-in.

7.Symptomatic hypotension (eg. Dizziness with SBP <110 mm Hg systolic) during the run-in phase.

8.Chronic liver disease or abnormal liver function, i.e. ALT or AST >3 x ULN.

9.Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine kinase (CK) > 3x ULN.

10.Severe renal impairment (serum creatinine >264 µmol/L).

11.History of malignancy affecting any organ system, except basal cell carcinoma of the skin, within the previous 5 years.

12.Other serious conditions(s) likely to interfere with study participation or with the ability to complete the trial.

13.Concurrent use of any experimental pharmacological agent.

14.Inability to attend follow-up as required by the protocol for at least 5 years.

15. Expected long term use of anticoagulants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of CV death, Non fatal stroke, Non fatal MI.Timepoint: Every six months for an average follow up period of five years.

Secondary Outcome Measures

Name	Time	Method
Heart failure, Resuscitated cardiac arrest, RevascularizationTimepoint: Every six months for an average follow up period of five years.