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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04848220




Registration number
NCT04848220
Ethics application status
Date submitted
14/04/2021
Date registered
19/04/2021
Date last updated
12/12/2023

Titles & IDs
Public title
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
Scientific 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
Secondary ID [1] 0 0
C5071002
Secondary ID [2] 0 0
APD791-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Microvascular Obstruction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Temanogrel
Treatment: Drugs - Placebo

Experimental: Stage A (Dose Cohort 1) and Stage B (Dose Group 1) -

Experimental: Stage A (Dose Cohort 2) and Stage B (Dose Group 2) -

Placebo comparator: Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2) -


Treatment: Drugs: Temanogrel
Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure)

Treatment: Drugs: Placebo
Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI)
Timepoint [1] 0 0
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
Secondary outcome [1] 0 0
Change From Baseline to Post-PCI for Coronary Flow Reserve (CFR)
Timepoint [1] 0 0
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
Secondary outcome [2] 0 0
Change From Baseline to Post-PCI for Fractional Flow Reserve (FFR)
Timepoint [2] 0 0
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
Secondary outcome [3] 0 0
Change From Baseline to Post-PCI for Corrected Thrombolysis in Myocardial Infarction Frame Count (cTFC)
Timepoint [3] 0 0
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
Secondary outcome [4] 0 0
Number of Participants According to Change From Baseline to Post-PCI for Thrombolysis in Myocardial Infarction (TIMI) Flow Grade (TFG) Post-PCI
Timepoint [4] 0 0
Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
Secondary outcome [5] 0 0
Number of Participants According to Change From Baseline to Post-PCI in Thrombolysis in Myocardial Infarction Myocardial Perfusion Grade (TMPG) Post-PCI
Timepoint [5] 0 0
Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
Secondary outcome [6] 0 0
Change From Baseline to Post-PCI for Creatine Kinase (CK)
Timepoint [6] 0 0
Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge
Secondary outcome [7] 0 0
Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB)
Timepoint [7] 0 0
Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
Secondary outcome [8] 0 0
Change From Baseline to Post-PCI for Cardiac Troponin I
Timepoint [8] 0 0
Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
Secondary outcome [9] 0 0
Number of Participants With Procedural Myocardial Injury
Timepoint [9] 0 0
At 6 hours and 24 hours post-PCI/discharge on Day 1
Secondary outcome [10] 0 0
Concentration of Temanogrel
Timepoint [10] 0 0
Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Secondary outcome [11] 0 0
Concentration of AR295980
Timepoint [11] 0 0
Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Secondary outcome [12] 0 0
Concentration of AR295981
Timepoint [12] 0 0
Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Secondary outcome [13] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Timepoint [13] 0 0
From start of study treatment on day 1 to up to maximum of 10 days
Secondary outcome [14] 0 0
Number of Participants With Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation of Study Treatment and Treatment-Related TEAEs
Timepoint [14] 0 0
From start of study treatment on day 1 to up to maximum of 10 days
Secondary outcome [15] 0 0
Number of Participants With Treatment-Related TEAEs According to the Preferred Term
Timepoint [15] 0 0
From start of study treatment on day 1 to up to maximum of 10 days

Eligibility
Key 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
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2022
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Alfred Health - The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
Netherlands
State/province [3] 0 0
Gelderland
Country [4] 0 0
Netherlands
State/province [4] 0 0
South Holland
Country [5] 0 0
Netherlands
State/province [5] 0 0
Eindhoven
Country [6] 0 0
Sweden
State/province [6] 0 0
Lund
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Stevenage

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arena is a wholly owned subsidiary of Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04848220
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04848220