At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 126 enrolled
Drug / intervention
MDCO-216 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-controlled, Double-blind, Randomized Trial to Compare the Effect of Treatment on Plaque Burden as Determined by Intravascular Ultrasound and to Evaluate the Efficacy, Pharmacokinetics, Safety, and Tolerability of MDCO-216 Given as Multiple Weekly Infusions in Subjects With a Recent Acute Coronary Syndrome
In Brief
A Phase 2 clinical trial evaluating MDCO-216 and Placebo for Acute Coronary Syndrome. Completed, enrolled 126 participants across 20 sites in 5 countries.
Detailed Summary
This study will be a proof-of-concept, placebo-controlled, double-blind, randomized trial in participants with a recent acute coronary syndrome (ACS) to evaluate the efficacy, pharmacokinetics, safety, tolerability, disease progression measures by IVUS, and pharmacodynamics of MDCO-216 infusion. Eligible participants will be randomized to receive 5 infusions of MDCO-216 20 milligrams/kilogram (mg/kg) or placebo in a 1:1 ratio.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
CountriesCanada, Czechia, Hungary, Netherlands, Poland
CollaboratorsThe Cleveland Clinic
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedFeb 2016
Primary CompletionOct 2016
TodayJul 2026
First PostedFeb 10, 2016
Enrollment StartDec 3, 2015
Primary CompletionOct 26, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.4 years ago
Interventions
MDCO-216drug
Placebodrug