Study Stopped
Business decision
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
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
2 other identifiers
interventional
29
5 countries
12
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2021
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedResults Posted
Study results publicly available
December 12, 2023
CompletedDecember 12, 2023
November 1, 2023
1.3 years
April 14, 2021
August 18, 2023
November 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI)
IMR was defined as the mean distal pressure at maximum hyperemia multiplied by the mean hyperemic transit time. IMRcorr (IMR corrected for the influence from collateral supply) was calculated using the following equation, to account for the presence of significant epicardial stenosis without the need for balloon dilation to measure the coronary wedge pressure (Pw), IMRcorr = mean aortic pressure at maximum hyperemia (Pa)\*mean transit time at maximal hyperemia (Tmn) \* \[1.34 \* mean distal coronary pressure at maximum hyperemia (Pd)/Pa minus 0.32\].
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
Secondary Outcomes (15)
Change From Baseline to Post-PCI for Coronary Flow Reserve (CFR)
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
Change From Baseline to Post-PCI for Fractional Flow Reserve (FFR)
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
Change From Baseline to Post-PCI for Corrected Thrombolysis in Myocardial Infarction Frame Count (cTFC)
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
Number of Participants According to Change From Baseline to Post-PCI for Thrombolysis in Myocardial Infarction (TIMI) Flow Grade (TFG) Post-PCI
Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
Number of Participants According to Change From Baseline to Post-PCI in Thrombolysis in Myocardial Infarction Myocardial Perfusion Grade (TMPG) Post-PCI
Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
- +10 more secondary outcomes
Study Arms (3)
Stage A (Dose Cohort 1) and Stage B (Dose Group 1)
EXPERIMENTALStage A (Dose Cohort 2) and Stage B (Dose Group 2)
EXPERIMENTALStage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2)
PLACEBO COMPARATORInterventions
Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure)
Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Arena is a wholly owned subsidiary of Pfizercollaborator
Study Sites (12)
Tibor Rubin VA Medical Center
Long Beach, California, 90822-5201, United States
VA Palo Alto - Cardiac Catheterization Laboratory
Palo Alto, California, 94304, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Alfred Health - The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA, Netherlands
Maasstad Hospital
Rotterdam, South Holland, 3079 DZ, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
Skåne University Hospital
Lund, 221 85, Sweden
East and North Hertfordshire NHS Trust Lister Hospital
Stevenage, SG1 4AB, United Kingdom
Related Links
MeSH Terms
Interventions
Limitations and Caveats
This study was terminated early due to a business decision that was not due to any safety concerns. The number of participants was smaller than originally planned and only summary statistics were therefore generated for primary and secondary outcome measures.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2021
First Posted
April 19, 2021
Study Start
May 20, 2021
Primary Completion
August 23, 2022
Study Completion
August 31, 2022
Last Updated
December 12, 2023
Results First Posted
December 12, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.