Clinical trial NCT04848220: A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
Official title: 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 Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Microvascular Obstruction
Keywords: Temanogrel
Microvascular obstruction
APD791
Percutaneous coronary intervention
MVO
PCI
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Arena is a wholly owned subsidiary of Pfizer
First posted: 2021-04-19
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intravenous temanogrel is a safe and effective treatment for microvascular obstruction (MVO) in adult participants undergoing percutaneous coronary intervention (PCI).

Detailed description: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to be conducted in 2 stages (Stage A and Stage B). Stage A is an ascending single-dose placebo-controlled study planned to consist of 2 cohorts. Stage B is a parallel-treatment group study planned to consist of a placebo group and 2 active treatment groups of temanogrel doses selected based on safety and tolerability data in Stage A.

Eligibility criteria: Inclusion Criteria:

* Stable angina participants suitable for elective PCI, or participants suitable for PCI for diagnosis of non-ST-elevation myocardial infarction or unstable angina (NSTEMI/UA) who are 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 and must satisfy the study criteria regarding lesion size and vessel diameter/type.
* Females must not be of childbearing potential
* Males with pregnant or non-pregnant female partners of childbearing potential must agree to using a condom during treatment and for 90 days following treatment

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 4 months of Screening

Primary outcomes:
measure: Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI)
timeFrame: From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
Secondary outcomes:
measure: Change From Baseline to Post-PCI for Coronary Flow Reserve (CFR)
timeFrame: From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
measure: Change From Baseline to Post-PCI for Fractional Flow Reserve (FFR)
timeFrame: From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
measure: Change From Baseline to Post-PCI for Corrected Thrombolysis in Myocardial Infarction Frame Count (cTFC)
timeFrame: From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
measure: Number of Participants According to Change From Baseline to Post-PCI for Thrombolysis in Myocardial Infarction (TIMI) Flow Grade (TFG) Post-PCI
timeFrame: Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
measure: Number of Participants According to Change From Baseline to Post-PCI in Thrombolysis in Myocardial Infarction Myocardial Perfusion Grade (TMPG) Post-PCI
timeFrame: Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
measure: Change From Baseline to Post-PCI for Creatine Kinase (CK)
timeFrame: Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge
measure: Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB)
timeFrame: Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
measure: Change From Baseline to Post-PCI for Cardiac Troponin I
timeFrame: Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
measure: Number of Participants With Procedural Myocardial Injury
timeFrame: At 6 hours and 24 hours post-PCI/discharge on Day 1
measure: Concentration of Temanogrel
timeFrame: Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
measure: Concentration of AR295980
timeFrame: Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
measure: Concentration of AR295981
timeFrame: Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
timeFrame: From start of study treatment on day 1 to up to maximum of 10 days
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation of Study Treatment and Treatment-Related TEAEs
timeFrame: From start of study treatment on day 1 to up to maximum of 10 days
measure: Number of Participants With Treatment-Related TEAEs According to the Preferred Term
timeFrame: From start of study treatment on day 1 to up to maximum of 10 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Tibor Rubin VA Medical Center
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto - Cardiac Catheterization Laboratory
state: California
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Health - The Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
state: South Holland
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Stevenage
country: United Kingdom
facility: East and North Hertfordshire NHS Trust Lister Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: