| 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]. | FAS included all randomized participants, irrespective of whether they received any study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Millimeter of mercury*seconds | | From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. | | OG002 | Placebo | Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-8.1783± 15.35531
- OG0010.0691± 13.27702
- OG002-1.8907± 18.82659
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| 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. | FAS included all randomized participants, irrespective of whether they received any study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Ratio | | From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. | | OG002 | Placebo | Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| 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]). | FAS included all randomized participants, irrespective of whether they received any study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Ratio | | From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. | | OG002 | Placebo | |
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| 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. | Safety set included all participants in the FAS who received any study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Frames per second | | From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. | | OG002 | Placebo | |
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| 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. | Safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Count of Participants | | Participants | | Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. | | OG002 | Placebo | |
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| 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. | Safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Count of Participants | | Participants | | Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| Secondary | Change From Baseline to Post-PCI for Creatine Kinase (CK) | | Safety Set included all participants in the FAS who received any study treatment. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Units per liter | | Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. | | OG002 | Placebo | Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| Secondary | Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB) | | Safety Set included all participants in the FAS who received any study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Micrograms per liter | | Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. | | OG002 | Placebo | Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| Secondary | Change From Baseline to Post-PCI for Cardiac Troponin I | | Safety Set included all participants in the FAS who received any study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Microgram per liter | | Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. | | OG002 | Placebo | Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| 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). | Safety Set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here 'Number Analyzed' indicates number of participants evaluable at the specified timepoints. | Posted | | Count of Participants | | Participants | | At 6 hours and 24 hours post-PCI/discharge on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| Secondary | Concentration of Temanogrel | Observed plasma concentration of temanogrel. Lower limit of quantification (LLOQ) of temanogrel was 0.500 nanograms/milliliter (ng/mL). | Pharmacokinetic (PK) set included all participants in the Safety Set with at least 1 post dose PK measurement. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| Secondary | Concentration of AR295980 | Observed plasma concentration of AR295980. | PK set will include all participants in the Safety Set with at least 1 post dose PK measurement. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| Secondary | Concentration of AR295981 | Observed plasma concentration of AR295981. | PK set included all participants in the Safety Set with at least 1 post dose PK measurement. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| 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. | The safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Count of Participants | | Participants | | From start of study treatment on day 1 to up to maximum of 10 days | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. |
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| 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. | The safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Count of Participants | | Participants | | From start of study treatment on day 1 to up to maximum of 10 days | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | |
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| 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. | The safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol. | Posted | | Count of Participants | | Participants | | From start of study treatment on day 1 to up to maximum of 10 days | | | | ID | Title | Description |
|---|
| OG000 | Temanogrel 20 mg | Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment. | | OG001 | Temanogrel 40 mg | Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment. | | OG002 |
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