Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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 |
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. |
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1 |
|
| Secondary |
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]). |
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1 |
|
| Secondary |
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. |
From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1 |
|
| Secondary |
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. |
Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1 |
|
| Secondary |
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. |
Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1 |
|
| Secondary |
Change From Baseline to Post-PCI for Creatine Kinase (CK) |
|
Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge |
|
| Secondary |
Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB) |
|
Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge |
|
| Secondary |
Change From Baseline to Post-PCI for Cardiac Troponin I |
|
Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge |
|
| Secondary |
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). |
At 6 hours and 24 hours post-PCI/discharge on Day 1 |
|
| Secondary |
Concentration of Temanogrel |
Observed plasma concentration of temanogrel. Lower limit of quantification (LLOQ) of temanogrel was 0.500 nanograms/milliliter (ng/mL). |
Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge |
|
| Secondary |
Concentration of AR295980 |
Observed plasma concentration of AR295980. |
Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge |
|
| Secondary |
Concentration of AR295981 |
Observed plasma concentration of AR295981. |
Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge |
|
| Secondary |
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. |
From start of study treatment on day 1 to up to maximum of 10 days |
|
| Secondary |
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. |
From start of study treatment on day 1 to up to maximum of 10 days |
|
| Secondary |
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. |
From start of study treatment on day 1 to up to maximum of 10 days |
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