A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL ASSESSING THE IMPACT OF LIPOPROTEIN (A) LOWERING WITH TQJ230 ON MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH ESTABLISHED CARDIOVASCULAR DISEASE

Not Applicable

Recruiting

Conditions: -I516 Cardiovascular disease, unspecified
Cardiovascular disease, unspecified
I516

Registration Number: PER-085-20

Lead Sponsor: ovartis Pharma AG.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Written informed consent.
2. Male and female 18 to ≤ 80 years of age.
3. Lp(a) ≥ 70 mg/dL at the screening visit.
4. LDL-cholesterol lowering treatment at Randomization.
5. Subjects must be optimally treated for other CV risk factors according to local practice/guidelines.
6. Established CV disease.

Exclusion Criteria

1. Uncontrolled hypertension.
2. Treatment with niacin .
3. Treatment with stable dose of a PCSK9 inhibitor.
4. Treatment with lipoprotein apheresis.
5. Within 3 months of screening: myocardial infarction, stroke, coronary or lower limb re-vascularization, major cardiac or non-cardiac surgery.
6. Cardiac, cerebrovascular or peripheral artery surgery or coronary revascularization after D1.
7. NYHA class IV.
8. Hemorrhagic stroke.
9. Severe concomitant non-CV disease.
10. Severe infection or hematologic, metabolic, gastrointestinal or endocrine dysfunction.
11. Malignancy of any organ system.
12. Lab analyses within limits.
13. Positive HIV, Hepatitis C or Hepatitis B.
14.Treatment with an oligonucleotide or SiRNA.
15.Hypersensitivity to the study drug.
16. Use of other investigational drugs.
17.Pregnant or nursing women.
18.Women of child-bearing potential unless using highly effective methods of contraception.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Time-to-event is<br>computed as the number<br>of days from<br>randomization to the<br>onset of the primary<br>endpoint event.<br>Measure:Time to first occurrence<br>of an expanded MACE<br>(cardiovascular death,<br>non-fatal MI, non-fatal<br>stroke and urgent<br>coronary revascularization<br>requiring<br>hospitalization).<br>Timepoints:Double-blind<br>treatment period<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Number of days from<br>randomization to the<br>first occurrence of the<br>CEC confirmed<br>composite endpoint of<br>MACE<br>Measure:Time to the first<br>occurrence of the CEC<br>confirmed composite<br>endpoint of MACE (CV<br>death, non-fatal MI,<br>and non-fatal stroke).<br><br>Timepoints:Double-blind<br>treatment period<br>;<br>Outcome name:Number of days from<br>randomization to the<br>first occurrence of the<br>CEC confirmed<br>composite endpoint of<br>CHD<br>Measure:Time to the first<br>occurrence of the CEC<br>confirmed composite<br>endpoint of coronary<br>heart diesase (CHD) outcomes (CHD<br>death, non-fatal MI,<br>urgent coronary revascularization<br>requiring<br>hospitalization).<br>Timepoints:Double-blind<br>treatment period<br>;<br>Outcome name:Number of days from<br>randomization to death<br>Measure:Time to all-cause death<br>from randomization to<br>the end of study.<br>Timepoints:End of study.<br>

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Study & Design

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