Assessing the Impact of TQJ230 in reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Phase 3

• Conditions: Health Condition 1: I998- Other disorder of circulatory system

• Registration Number: CTRI/2020/07/026538
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.

2. Male and female 18 to = 80 years of age

3. Lp(a) = 70 mg/dL at the screening visit, measured at the Central laboratory

4. LDL-cholesterol lowering treatment at Randomization as follows:

a. subjects must be on an optimal LDL-C lowering treatment to meet the target LDL-C

level according to local practice/guidelines, or

b. if subjects do not meet the target LDL-C level according to local practice/guidelines,

they should be treated with the highest tolerated doses of statins and/or with other

optimized LDL-lowering therapy (e.g. ezetimibe, cholesterol absorption inhibitor,

fibrate, PCSK9 inhibitor), or

c. if subjects have a contraindication or do not tolerate statin treatment, they must be

treated with other optimized LDL-lowering therapy (e.g. ezetimibe, cholesterol

absorption inhibitor, fibrate, PCSK9 inhibitor) according to local practice/guidelines

5. At the randomization visit subjects must be optimally treated for other CV risk factors

according to local practice/guidelines

Exclusion Criteria

1. Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) = 160 mmHg

and/ or diastolic blood pressure (DBP) = 100 mmHg (mean of 3 measurements for each

SBP and DBP assessment) at the Screening visit.

2. Treatment with niacin in the 3 months before the screening visit; niacin in multi-vitamins

is allowed

3. Treatment with stable dose of a PCSK9 inhibitor (evolocumab, alirocumab) for less than

12 weeks before Randomization

4. Treatment with lipoprotein apheresis, or already planned to start lipoprotein apheresis

during the study

5. Within 3 months of screening and between Screening visit and Randomization visit (Day

1): myocardial infarction, stroke, coronary or lower limb re-vascularization, major cardiac

or non-cardiac surgery. The subjects can be re-screened 3 months after the relevant

event/procedure.

6. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary revascularization

after Randomization visit (Day 1)

7. Heart failure New York Heart Association (NYHA) class IV at Screening visit or

at Randomization visit (Day 1)

8. History of hemorrhagic stroke or other major bleeding, or if occurring between Screening

visit and Randomization visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified