A double-blind, randomized, placebo-controlled multicenter phase III study to investigate the efficacy and safety of CSL112 in patients with acute coronary syndrome

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Estonia, European Union, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States (ICTRP)

Identifiant de l'essai ICTRP
EUCTR2017-000996-98 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
non disponible

Titre académique
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome - AEGIS-II / ApoA-I Event reducinG in Ischemic Syndromes II (ICTRP)

Titre public
Study to Investigate CSL112 in Subjects with Acute Coronary Syndrome (ICTRP)

Maladie en cours d'investigation
Acute Coronary Syndrome
MedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] (ICTRP)

Intervention étudiée

Product Name: Apolipoprotein A-I [human] (apoA-I) purified from human plasma
Product Code: CSL112
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: Apolipoprotein A-I [human]
CAS Number: 1361928-49-5
Current Sponsor code: CSL112
Other descriptive name: APOLIPOPROTEIN A-I, HUMAN; Apolipoprotein A-I , Apolipoprotein A1, Apo-AI, ApoA-I
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

(ICTRP)

Type d'essai
Interventional clinical trial of medicinal product (ICTRP)

Plan de l'étude
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2 (ICTRP)

Critères d'inclusion/exclusion
Gender:
Female: yes
Male: yes

Inclusion criteria:
1. Male or female least 18 years of age
2. Evidence of myocardial necrosis, consistent with type (spontaneous) MI
3. No suspicion of acute kidney injury
4. Evidence of multivessel coronary artery disease and at least 1 of the following established risk factors:age = 65 years, prior history of MI, diabetes mellitus, or peripheral artery disease
5. Presence of established cardiovascular risk factor(s):
a. Diabetes mellitus on pharmacotherapy OR
b. 2 or more of the following: age = 65 years, prior history of MI, peripheral arterial disease


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 6960
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10440
(ICTRP)

Exclusion criteria:
1. Ongoing hemodynamic instability
2. Evidence of hepatobiliary disease
3. Evidence of severe chronic kidney disease
4. Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI
5. Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin


Critères d'évaluation principaux et secondaires
Main Objective: To evaluate the efficacy of CSL112 in reducing the risk of MACE [Major adverse cardiovascular event(s)][ (CV (cardiovascular)death, MI (Myocardial Infarction), or stroke)] in subjects with ACS (Acute Coronary Syndrome),[diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI(Non-ST-segment elevation myocardial infarction)].
;Secondary Objective: 1. To evaluate the efficacy of CSL112 on reducing the total number of hospitalizations for coronary, cerebral, or peripheral ischemia.
2. To evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) in ACS (diagnosed with STEMI or NSTEMI) through 180 and 365 days
;Primary end point(s): Time to first occurrence of any component of composite MACE (CV death, MI, or stroke ) ;Timepoint(s) of evaluation of this end point: Through 90 days (ICTRP)

Secondary end point(s): 1) Total number of hospitalizations for coronary, cerebral, or peripheral
ischemia
2) and 3) Time to first occurrence of CV death, MI, or stroke
4) Time to occurrence of CV death
5) Time to first occurrence of MI
6) Time to first occurrence of stroke
7) Time to first occurrence of CV death, type 1 MI, or stroke
8) Time to occurrence of all-cause death
9) Number and percent of subjects with adverse events
10) Number and percent of subjects with treatment-related adverse events
11) Number and percent of subjects with serious adverse events
12) Number and percent of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low);Timepoint(s) of evaluation of this end point: 1), 4), 5), 6), 9): Through 90 days
2): Through 180 days
3), 8), 10), 11): Through 365 days
7): Through 90, 180, and 365 days
12): Baseline and 29 days (ICTRP)

Date d'enregistrement
17.05.2019 (ICTRP)

Inclusion du premier participant
19.04.2019 (ICTRP)

Sponsors secondaires
non disponible

Contacts supplémentaires
Trial Registration Coordinator, clinicaltrials@cslbehring.com, +1484-878-4000, CSL Behring LLC (ICTRP)

ID secondaires
CSL112_3001, 2017-000996-98-GB (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000996-98 (ICTRP)