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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)
Assessment method [1] 0 0
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) \* \[1.34 \* mean distal coronary pressure at maximum hyperemia (Pd)/Pa minus 0.32\].
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)
Assessment method [1] 0 0
The coronary flow reserve (CFR) was calculated from the ratio of baseline (i.e., resting transit time) to hyperemic mean transit time.
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)
Assessment method [2] 0 0
The FFR was calculated from the ratio of distal to proximal mean pressures at maximal hyperemia (FFR = \[distal coronary pressure/aortic pressure at maximum hyperemia\]).
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)
Assessment method [3] 0 0
The cTFC is a quantitative index of coronary flow and was calculated based upon the number of cine-frames that the intracoronary dye required to reach distal coronary landmarks.
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
Assessment method [4] 0 0
The TFG is a measure of epicardial perfusion and was graded on a standard scale from 0 to 3, where Grade 0=no perfusion, grade 1=penetration without perfusion, grade 2=partial perfusion and grade 3= complete perfusion.
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
Assessment method [5] 0 0
The TMPG (also known as myocardial blush grade \[MBG\]), is a measure of myocardial perfusion in the capillary bed at the tissues level following contrast injection into the coronary artery. TMPG was graded on a scale from 0 to 3, where grade 0 = failure of dye to enter the microvasculature; grade 1 = dye slowly enters but fails to exit the microvasculature; grade 2 = delayed entry and exit of dye from the microvasculature; grade 3= normal entry and exit of dye from the microvasculature.
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)
Assessment method [6] 0 0
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)
Assessment method [7] 0 0
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
Assessment method [8] 0 0
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
Assessment method [9] 0 0
Procedural myocardial injury was defined as elevation of cardiac troponin (cTn) values greater than (\>) 99th percentile upper reference limit (URL) in participants with normal baseline values (\<= 99th percentile URL) or elevation of cTn by \> 20% of the baseline value in participants with elevated cTn levels (\>99th percentile URL).
Timepoint [9] 0 0
At 6 hours and 24 hours post-PCI/discharge on Day 1
Secondary outcome [10] 0 0
Concentration of Temanogrel
Assessment method [10] 0 0
Observed plasma concentration of temanogrel. Lower limit of quantification (LLOQ) of temanogrel was 0.500 nanograms/milliliter (ng/mL).
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
Assessment method [11] 0 0
Observed plasma 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
Assessment method [12] 0 0
Observed plasma 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
Assessment method [13] 0 0
An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 as grade 1: mild; grade 2: moderate; grade 3: severe, grade 4: life threatening, grade 5: death related to AE. Number of participants with any TEAE and grade 3 or higher TEAE have been reported.
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
Assessment method [14] 0 0
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect. Relatedness was based on investigator's assessment.
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
Assessment method [15] 0 0
An adverse event was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. Relatedness was based on investigator's assessment.
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
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arena is a wholly owned subsidiary of Pfizer
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


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