A blinded study to assess the safety, tolerability and effect of Temanogrel on Microvascular Obstruction in subjects undergoing Percutaneous Coronary Intervention (PCI).
- Conditions
- Microvascular ObstructionMedDRA version: 20.1Level: LLTClassification code 10079682Term: Microvascular occlusionSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-000238-16-SE
- Lead Sponsor
- Arena Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 99
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To assess the effect of temanogrel on MVO following PCI;Secondary Objective: 1. To assess the effect of temanogrel on selected coronary physiology indices and angiographic measures following PCI<br>2. To assess the effect of temanogrel on myocardial injury following PCI; <br>3. To assess the pharmacokinetics (PK) of temanogrel and its active metabolites AR295980 (M1) and AR295981 (M2) in subjects undergoing PCI;<br>4. To assess the safety and tolerability of temanogrel in subjects undergoing PCI;Primary end point(s): 1. Change in IMR from Baseline to Post-PCI<br>;Timepoint(s) of evaluation of this end point: 1. Baseline, pre-PCI, post-PCI.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change from Baseline to Post-PCI with temanogrel versus placebo for the following assessments:<br>• Coronary physiology indices (coronary flow reserve [CFR], fractional flow reserve [FFR]),<br>• Angiographic measures (corrected thrombolysis in myocardial infarction frame count [cTFC], TFG, thrombolysis in myocardial infarction myocardial perfusion grade [TMPG]),<br>• Myocardial injury markers (creatine kinase [CK], creatine kinase-myocardial band [CK-MB], cTn);<br>2. Incidence of Procedural Myocardial Injury;<br>3. Observed Maximum Plasma Concentration (Cmax) of Temanogrel and its Metabolites;<br>4. Safety and tolerability of temanogrel;Timepoint(s) of evaluation of this end point: 1-4. Baseline, pre-PCI, post-PCI.