Microvascular ObstructionPhase 2NCT04848220
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
A Phase 2 study testing Temanogrel in people with Microvascular Obstruction, run by Pfizer at 12 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Microvascular Obstruction
- What is being tested?
- Temanogrel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 20 May 2021to 31 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Australia4 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Alfred Health - The Alfred Hospital
Melbourne, Victoria, 3004
Royal Perth Hospital
Perth, Western Australia, 6000
United States3 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
Tibor Rubin VA Medical Center
Long Beach, California, 90822-5201
VA Palo Alto - Cardiac Catheterization Laboratory
Palo Alto, California, 94304
Netherlands3 sites
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA
Maasstad Hospital
Rotterdam, South Holland, 3079 DZ
United Kingdom1 site
East and North Hertfordshire NHS Trust Lister Hospital
Stevenage, SG1 4AB
About this study
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
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).
Read the 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.
- Conditions
- Microvascular Obstruction
- Being tested
- Temanogrel, Placebo
- Keywords
- Temanogrel, Microvascular obstruction, APD791, Percutaneous coronary intervention, MVO, PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemanogrelDrug
Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure)
PlaceboDrug
Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Stage A (Dose Cohort 1) and Stage B (Dose Group 1) | Experimental | Not described Receives: Drug: Temanogrel |
| Stage A (Dose Cohort 2) and Stage B (Dose Group 2) | Experimental | Not described Receives: Drug: Temanogrel |
| Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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)
The coronary flow reserve (CFR) was calculated from the ratio of baseline (i.e., resting transit time) to hyperemic mean transit time.
Measured: 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)
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]).
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
Change From Baseline to Post-PCI for Creatine Kinase (CK)
Measured: Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge
Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB)
Measured: Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
Change From Baseline to Post-PCI for Cardiac Troponin I
Measured: Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
Number of Participants With Procedural Myocardial Injury
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).
Measured: At 6 hours and 24 hours post-PCI/discharge on Day 1
Concentration of Temanogrel
Observed plasma concentration of temanogrel. Lower limit of quantification (LLOQ) of temanogrel was 0.500 nanograms/milliliter (ng/mL).
Measured: Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Concentration of AR295980
Observed plasma concentration of AR295980.
Measured: Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Concentration of AR295981
Observed plasma concentration of AR295981.
Measured: Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
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.
Measured: From start of study treatment on day 1 to up to maximum of 10 days
Number of Participants With Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation of Study Treatment and Treatment-Related TEAEs
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.
Measured: From start of study treatment on day 1 to up to maximum of 10 days
Number of Participants With Treatment-Related TEAEs According to the Preferred Term
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.
Measured: From start of study treatment on day 1 to up to maximum of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start20 May 2021
- Primary completion23 Aug 2022
- Study completion31 Aug 2022
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Microvascular ObstructionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arena is a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848220
- Sponsor's protocol ID
- APD791-202
- Other IDs
- C5071002
- Status last verified
- Nov 2023
- First submitted
- 14 Apr 2021
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04848220
- Acronym / sponsor ID
- APD791-202
- Conditions
- Microvascular Obstruction
- Keywords
- Temanogrel, Microvascular obstruction, APD791, Percutaneous coronary intervention, MVO, PCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Arena is a wholly owned subsidiary of Pfizer
- Study start
- 20 May 2021 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Posted 12 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage A (Dose Cohort 1) and Stage B (Dose Group 1) | Experimental | Drug: Temanogrel |
| Stage A (Dose Cohort 2) and Stage B (Dose Group 2) | Experimental | Drug: Temanogrel |
| Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemanogrelParticipants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure) | Drug | Stage A (Dose Cohort 1) and Stage B (Dose Group 1), Stage A (Dose Cohort 2) and Stage B (Dose Group 2) |
| PlaceboParticipants will receive a single intravenous dose of temanogrel matching placebo on Day 1 | Drug | Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2) |
Primary outcome
Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI)
Time frame: From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
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].
15 secondary outcomes
Change From Baseline to Post-PCI for Coronary Flow Reserve (CFR)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
Change From Baseline to Post-PCI for Creatine Kinase (CK)
Time frame: Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge
Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB)
Time frame: Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
Change From Baseline to Post-PCI for Cardiac Troponin I
Time frame: Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
Number of Participants With Procedural Myocardial Injury
Time frame: At 6 hours and 24 hours post-PCI/discharge on Day 1
Concentration of Temanogrel
Time frame: Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Concentration of AR295980
Time frame: Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Concentration of AR295981
Time frame: Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Time frame: From start of study treatment on day 1 to up to maximum of 10 days
Number of Participants With Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation of Study Treatment and Treatment-Related TEAEs
Time frame: From start of study treatment on day 1 to up to maximum of 10 days
Number of Participants With Treatment-Related TEAEs According to the Preferred Term
Time frame: From start of study treatment on day 1 to up to maximum of 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temanogrel in people with Microvascular Obstruction, run by Pfizer at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, United States, Netherlands, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI) (time frame: From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.