Microvascular Obstruction MedDRA version: 20.1 Level: LLT Classification code 10079682 Term: Microvascular occlusion System Organ Class: 100000004866
Conditions
Interventions
Product Name: Temanogrel
Product Code: APD791
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Temanogrel
CAS Number: 957466-27-2
Current Sponsor code: APD791
Other descriptive name: Te
Sponsors
Arena Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Stable angina patients referred for elective percutaneous coronary intervention (PCI), or non-ST-elevation myocardial infarction (NSTEMI) and unstable angina (UA) patients undergoing PCI at least 12 hours after diagnosis for NSTEMI/UA. NSTEMI/UA patients are to be consistently hemodynamically stable until the time of PCI and have a thrombolysis in myocardial infarction Grade 3 on the diagnostic angiography prior to PCI - Target lesions for PCI must appear suitable for stenting as confirmed on the diagnostic angiography prior to PCI. The lesion must be located in a =2.75 millimeter (mm) diameter coronary artery; the lesion must also be =18 mm long and require the use of one or more stents that in total must be =20 mm long. Acceptable lesions cannot be in the left main artery or in a vein or arterial graft, or be a chronic total occlusion or in-stent restenosis. Two or more sequential lesions may be treated in the same artery, as long as they are treated in the same session and at least one of the lesions meets inclusion criteria - Both men and women participants agree to use a highly effective method of birth control throughout the entire study period, from informed consent through the adverse event reporting period, if the possibility of conception exists 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 49
Exclusion criteria
Exclusion criteria: - Planned or anticipated use of rotational atherectomy/ablation or shockwave therapies during the PCI procedure; - Any history of stroke, head injury, seizure, intracranial bleeding, or intracranial aneurysm; - Transient ischemic attack within the 6 months prior to Screening; - History of major trauma, major surgery, and/or clinically significant hemorrhage within the last 6 months of Screening; - NSTEMI/UA with subsequent cardiac troponin levels that are increasing (not stable or dropping) as shown by the 2 most recent measures after diagnosis of NSTEMI/UA and prior to randomization; - Any ST-elevation myocardial infarction (STEMI) within 10 days of Screening or STEMI within the target vessel territory within the last 6 months of Screening (eg, a patient with a NSTEMI because of a lesion in a diagonal may not be included if there is a history of anterior STEMI due to left anterior descending artery lesion that occurred within the last 6 months); - Known history of heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To assess the effect of temanogrel on selected coronary physiology indices and angiographic measures following PCI 2. To assess the effect of temanogrel on myocardial injury following PCI; 3. To assess the pharmacokinetics (PK) of temanogrel and its active metabolites AR295980 (M1) and AR295981 (M2) in subjects undergoing PCI; 4. To assess the safety and tolerability of temanogrel in subjects undergoing PCI;Main Objective: 1. To assess the effect of temanogrel on MVO following PCI;Primary end point(s): 1. Change in IMR from Baseline to Post-PCI ;Timepoint(s) of evaluation of this end point: 1. Baseline, pre-PCI, post-PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from Baseline to Post-PCI for the following assessments: • Coronary physiology indices (coronary flow reserve [CFR], fractional flow reserve [FFR]), • Angiographic measures (corrected thrombolysis in myocardial infarction frame count [cTFC], TFG, thrombolysis in myocardial infarction myocardial perfusion grade [TMPG]), • Myocardial injury markers (creatine kinase [CK], creatine kinase-myocardial band [CK-MB], cTn); 2. Incidence of Procedural Myocardial Injury; 3. Observed Maximum Plasma Concentration (Cmax) of Temanogrel and its Metabolites; 4. Safety and tolerability of temanogrel;Timepoint(s) of evaluation of this end point: 1-4. Baseline, pre-PCI, post-PCI. | — |
Countries
Australia, Netherlands, Sweden, United Kingdom, United States
Contacts
Public ContactMehreen Hai
Arena Pharmaceuticals, Inc.
Outcome results
None listed