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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04848220