Atherosclerosis Percutaneous Coronary Intervention
Conditions
Interventions
The study drug is an IV formulation containing active pharmaceutical ingredient
provided as 25 mg/mL strength. Subjects will receive a single IV dose of study
treatment on Day 1 of the study.
The
Sponsors
Arena Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Stable angina patients suitable for elective PCI or patients suitable for PCI for diagnosis of NSTEMI/UA. NSTEMI/UA patients are to be consistently hemodynamically stable until the time of PCI and have a thrombolysis in myocardial infarction (TIMI) Flow Grade () 2 or 3 on the diagnostic angiography. - Target lesions for PCI must appear suitable for stenting as confirmed on the diagnostic angiography. 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: • For elective PCI patients and non-urgent NSTEMI/UA patients (PCI >12 hours after diagnosis), the lesion must be located in a >= 2.75 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. • For NSTEMI patients treated with PCI urgently (within 12 hours after diagnosis), the coronary artery diameter of the culprit lesion must be >= 2.75 mm. - 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
Exclusion criteria
Exclusion criteria: - Planned or anticipated use of rotational atherectomy/ablation or shockwave therapies during the PCI procedure; - Any history of stroke, 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 head injury or hemorrhage within the last 6 months of Screening; - 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 with reduced ejection fraction (HFrEF) defined as left ventricular ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: • Change in IMR from Baseline to Post PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: • Change from Baseline to Post PCI with the study drug versus placebo 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) • The incidence of procedural myocardial injury • Observed Maximum Plasma Concentration (Cmax) of study drug and its Metabolites; • Safety and tolerability of the study drug | — |
Countries
Netherlands
Outcome results
None listed