Clinical trial NCT04637555: Open-label Extension Study for CLCZ696G2301 (PARADISE-MI)
Official title: A Multicenter Study to Evaluate the Long-term Safety and Tolerability of Open-label LCZ696 in Patients With Acute Myocardial Infarction Who Previously Participated in CLCZ696G2301 (PARADISE-MI)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Post Myocardial Infarction
Keywords: LCZ696
Open-Label Extension
PARADISE-MI
Post Myocardial Infarction
Post Heart Attack
CLCZ696G2301
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a multicenter, open-label extension study following-up to PARADISE-MI, which evaluated the efficacy and safety of LCZ696 compared to ramipril, in reducing the occurrence of CV death, heart failure (HF) hospitalization and outpatient HF (time-to-first event analysis) in post-acute myocardial infarction (AMI) patients with evidence of left ventricular (LV) systolic dysfunction and/or pulmonary congestion, without a known prior history of chronic HF. The study duration is up to approximately 24 months with visits at Days -14 to 1, 1, 15, 29 and Months 3, 6, 12, 18, and 24. Participants will receive LCZ696 at maximally tolerated doses with a target dose of 200 mg twice daily at all visits between day 1 and the last visit.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect long-term safety and tolerability data of LCZ696 and to provide open-label LCZ696 to eligible participants who completed CLCZ696G2301 study (PARADISE-MI) if LCZ696 is shown to have a positive benefit-risk profile in comparison to ramipril in reducing risk of cardiovascular (CV) mortality and development of heart failure in participants enrolled in the PARADISE-MI study.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Participant received study treatment (either in LCZ696 or ramipril treatment arm) in PARADISE-MI.
3. Participant is safe to be enrolled in the extension study and may benefit from the treatment of LCZ696 per investigator's clinical judgement.

Exclusion Criteria:

1. Participant with a known history of angioedema
2. History of hypersensitivity to the study drug or drugs of similar chemical classes or known intolerance or contraindications to study drug or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors
3. Symptomatic hypotension at screening
4. Serum potassium \> 5.2 mmol /L (or equivalent plasma potassium value) at screening
5. Known hepatic impairment (as evidenced by total bilirubin \> 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices
6. Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
7. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of participants with AE(s) leading to permanent study drug discontinuation, temporary study drug interruption, or study drug dose adjustment will be reported and summarized
timeFrame: Up to 24 months
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to 24 months
measure: Vital signs (Blood Pressure and pulse)
timeFrame: Baseline and up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: