A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Effect on Microvascular Obstruction of Temanogrel in Subjects Undergoing Percutaneous Coronary Interventio
- Conditions
- AtherosclerosisPercutaneous Coronary Intervention10011082
- Registration Number
- NL-OMON51876
- Lead Sponsor
- Arena Pharmaceuticals, Inc.
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 27
- 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
- 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 <= 40% prior to current hospital admission.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>• Change in IMR from Baseline to Post PCI</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>• Change from Baseline to Post PCI with the study drug versus placebo for the<br /><br>following assessments:<br /><br>- Coronary physiology indices (coronary flow reserve [CFR], fractional<br /><br>flow reserve [FFR])<br /><br>- Angiographic measures (corrected thrombolysis in myocardial infarction<br /><br>frame count [cTFC], TFG, thrombolysis in myocardial infarction<br /><br>myocardial perfusion grade [TMPG])<br /><br>- Myocardial injury markers (creatine kinase [CK], creatine kinase<br /><br>myocardial band [CK MB], cTn)<br /><br><br /><br>• The incidence of procedural myocardial injury<br /><br>• Observed Maximum Plasma Concentration (Cmax) of study drug and its<br /><br>Metabolites;<br /><br>• Safety and tolerability of the study drug</p><br>