Assessing the Impact of TQJ230 in reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
Phase 3
Recruiting
- Conditions
- Other disorder of circulatory system,
- Registration Number
- CTRI/2020/07/026538
- Lead Sponsor
- Novartis Healthcare Pvt Ltd
- Brief Summary
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 7680
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed.
- 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
- 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.
- 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.
- 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
- Primary Outcome Measures
Name Time Method Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular Time to the first occurrence of CEC confirmed | expanded MACE (cardiovascular death, nonfatal | MI, non-fatal stroke and urgent coronary | re-vascularization requiring hospitalization) in a | population of patients with elevated Lp(a) ≥ 70 | mg/dL and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization Time to the first occurrence of CEC confirmed | expanded MACE (cardiovascular death, nonfatal | MI, non-fatal stroke and urgent coronary | re-vascularization requiring hospitalization) in a | population of patients with elevated Lp(a) ≥ 70 | mg/dL and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL requiring hospitalization) in the overall study population with established CVD Time to the first occurrence of CEC confirmed | expanded MACE (cardiovascular death, nonfatal | MI, non-fatal stroke and urgent coronary | re-vascularization requiring hospitalization) in a | population of patients with elevated Lp(a) ≥ 70 | mg/dL and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL and (Lp(a) ≥ 70 mg/dL) and/or Lp(a) ≥ 90 mg/dL. Time to the first occurrence of CEC confirmed | expanded MACE (cardiovascular death, nonfatal | MI, non-fatal stroke and urgent coronary | re-vascularization requiring hospitalization) in a | population of patients with elevated Lp(a) ≥ 70 | mg/dL and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL
- Secondary Outcome Measures
Name Time Method Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke) Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the MACE composite of CV death, nonfatal MI and non-fatal stroke. Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, nonfatal MI and urgent coronary revascularization requiring hospitalization. Number of participants with confirmed all-cause death Evaluation by clinical endpoint committee the rate of all-cause death
Trial Locations
- Locations (50)
Aakash healthcare Private Limited Hospital
🇮🇳Delhi, DELHI, India
Amrita Institute of Medical Sciences & Research Centre
🇮🇳Ernakulam, KERALA, India
Apollo Hospitals
🇮🇳Chennai, TAMIL NADU, India
Apollo Hospitals International Limited
🇮🇳Ahmadabad, GUJARAT, India
APOLLO SPECIALITY HOSPITALS
🇮🇳Madurai, TAMIL NADU, India
Artemis Hospitals
🇮🇳Gurgaon, HARYANA, India
Aster Medcity Hospital
🇮🇳Ernakulam, KERALA, India
B M Birla Heart Research Centre
🇮🇳Kolkata, WEST BENGAL, India
B.J. Govt. Medical College & Sassoon General Hospital
🇮🇳Pune, MAHARASHTRA, India
Bhaktivedanta Hospital and Research Institute
🇮🇳Thane, MAHARASHTRA, India
Scroll for more (40 remaining)Aakash healthcare Private Limited Hospital🇮🇳Delhi, DELHI, IndiaDr Ashish AgarwalPrincipal investigator9569060809medashish@rediffmail.com