CV Risk Reduction study (Reduction in Recurrent Major CV Disease Events)

Phase 1

• Conditions: atherosclerosis; MedDRA version: 20.0Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-022970-14-SK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-24
• Study Completion: 2019-04-14
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10061

Inclusion Criteria

- Written informed consent
- Male, or Female of non-child-bearing potential
- Age = 18 years
- Spontaneous MI at least 30 days before randomization.
- hsCRP = 2 mg/L
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 7000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3000

Exclusion Criteria

- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Any of the following concomitant diseases:
1. Planned coronary revascularization (PCI or CABG)
2. Major non-cardiac surgical or endoscopic procedure within past 6 months
3. Multi-vessel CABG surgery within the past 3 years Symptomatic patients with Class IV heart failure (HF) (New York Heart Association [NYHA]
4. Uncontrolled hypertension
5. Uncontrolled diabetes
- History or evidence of active tuberculosis (TB) infection
Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified