A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
TerminatedPhase 2Results postedLast updated 12 December 2023
What this trial tests
Phase 2 trial testing Temanogrel in Microvascular Obstruction in 29 participants. Terminated before completion.
Adults 30 to 80, any sex, with Microvascular Obstruction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI)Primary· 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) \* \[1.34 \* mean distal coronary pressure at maximum hyperemia (Pd)/Pa minus 0.32\].
Group
Value
95% CI
Temanogrel 20 mg
-8.1783
± 15.35531
Temanogrel 40 mg
0.0691
± 13.27702
Placebo
-1.8907
± 18.82659
Change From Baseline to Post-PCI for Coronary Flow Reserve (CFR)Secondary· From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
The coronary flow reserve (CFR) was calculated from the ratio of baseline (i.e., resting transit time) to hyperemic mean transit time.
Group
Value
95% CI
Temanogrel 20 mg
1.2744
± 0.89307
Temanogrel 40 mg
1.0238
± 2.97729
Placebo
1.3787
± 1.40440
Change From Baseline to Post-PCI for Fractional Flow Reserve (FFR)Secondary· From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
The FFR was calculated from the ratio of distal to proximal mean pressures at maximal hyperemia (FFR = \[distal coronary pressure/aortic pressure at maximum hyperemia\]).
Group
Value
95% CI
Temanogrel 20 mg
0.1346
± 0.19620
Temanogrel 40 mg
0.2494
± 0.20758
Placebo
0.3123
± 0.16562
Change From Baseline to Post-PCI for Corrected Thrombolysis in Myocardial Infarction Frame Count (cTFC)Secondary· From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
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.
Group
Value
95% CI
Temanogrel 20 mg
-6.54
± 7.365
Temanogrel 40 mg
-0.81
± 6.320
Placebo
-8.93
± 8.368
Number of Participants According to Change From Baseline to Post-PCI for Thrombolysis in Myocardial Infarction (TIMI) Flow Grade (TFG) Post-PCISecondary· Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
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 Grade 3
Group
Value
95% CI
Temanogrel 20 mg
10
Temanogrel 40 mg
8
Placebo
9
0 to 15 min post-PCI Grade 3
Group
Value
95% CI
Temanogrel 20 mg
9
Temanogrel 40 mg
8
Placebo
8
0 to 15 min post-PCI missing
Group
Value
95% CI
Temanogrel 20 mg
1
Temanogrel 40 mg
0
Placebo
1
Number of Participants According to Change From Baseline to Post-PCI in Thrombolysis in Myocardial Infarction Myocardial Perfusion Grade (TMPG) Post-PCISecondary· Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
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 TMPG value 2
Group
Value
95% CI
Temanogrel 20 mg
1
Temanogrel 40 mg
0
Placebo
1
Baseline TMPG value 3
Group
Value
95% CI
Temanogrel 20 mg
7
Temanogrel 40 mg
4
Placebo
3
Baseline Missing
Group
Value
95% CI
Temanogrel 20 mg
2
Temanogrel 40 mg
4
Placebo
5
0 to 15 min post-PCI TMPG value 3
Group
Value
95% CI
Temanogrel 20 mg
9
Temanogrel 40 mg
6
Placebo
6
0 to 15 min post-PCI Missing
Group
Value
95% CI
Temanogrel 20 mg
1
Temanogrel 40 mg
2
Placebo
3
Change From Baseline to Post-PCI for Creatine Kinase (CK)Secondary· Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge
0 to 15 minutes post-PCI
Group
Value
95% CI
Temanogrel 20 mg
-11.7
± 11.25
Temanogrel 40 mg
-6.0
± 5.68
Placebo
-5.9
± 10.58
6 hours post-PCI
Group
Value
95% CI
Temanogrel 20 mg
0.9
± 17.20
Temanogrel 40 mg
1.5
± 27.07
Placebo
-23.5
± 41.03
24 hours post- PCI/discharge
Group
Value
95% CI
Temanogrel 20 mg
-33.7
± 23.42
Temanogrel 40 mg
233.0
± NA
Placebo
-6.0
± 38.94
Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB)Secondary· Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
0 to 15 minutes Post-PCI
Group
Value
95% CI
Temanogrel 20 mg
-0.18
± 0.290
Temanogrel 40 mg
-0.18
± 0.225
Placebo
-0.26
± 0.490
6 Hours Post-PCI
Group
Value
95% CI
Temanogrel 20 mg
0.70
± 1.260
Temanogrel 40 mg
0.79
± 2.208
Placebo
-0.63
± 1.359
24 Hours Post- PCI/Discharge
Group
Value
95% CI
Temanogrel 20 mg
-0.05
± 0.804
Temanogrel 40 mg
31.80
± NA
Placebo
0.97
± 0.643
Change From Baseline to Post-PCI for Cardiac Troponin ISecondary· Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
0 to 15 minutes Post-PCI
Group
Value
95% CI
Temanogrel 20 mg
-0.04
± 0.126
Temanogrel 40 mg
0.01
± 0.035
Placebo
0.04
± 0.052
6 Hours Post-PCI
Group
Value
95% CI
Temanogrel 20 mg
0.58
± 1.310
Temanogrel 40 mg
0.13
± 0.354
Placebo
0.08
± 0.204
24 Hours Post- PCI/Discharge
Group
Value
95% CI
Temanogrel 20 mg
-0.03
± 0.197
Temanogrel 40 mg
5.50
± NA
Placebo
0.30
± 0.300
Number of Participants With Procedural Myocardial InjurySecondary· At 6 hours and 24 hours post-PCI/discharge on Day 1
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).
6 Hours Post-PCI
Group
Value
95% CI
Temanogrel 20 mg
3
Temanogrel 40 mg
1
Placebo
1
24 Hours Post-PCI/Discharge
Group
Value
95% CI
Temanogrel 20 mg
1
Temanogrel 40 mg
1
Placebo
2
Concentration of TemanogrelSecondary· Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Observed plasma concentration of temanogrel. Lower limit of quantification (LLOQ) of temanogrel was 0.500 nanograms/milliliter (ng/mL).
Pre-PCI
Group
Value
95% CI
Temanogrel 20 mg
1558.3889
± 2156.89423
Temanogrel 40 mg
1869.8571
± 1815.65878
0 to 15 minutes post PCI
Group
Value
95% CI
Temanogrel 20 mg
126.9900
± 31.08320
Temanogrel 40 mg
265.0000
± 109.83260
1 hour post PCI
Group
Value
95% CI
Temanogrel 20 mg
84.8667
± 24.45278
Temanogrel 40 mg
134.1667
± 36.56455
3 hours post PCI
Group
Value
95% CI
Temanogrel 20 mg
41.8500
± 17.23969
Temanogrel 40 mg
87.1714
± 90.12348
6 hours post PCI
Group
Value
95% CI
Temanogrel 20 mg
24.6522
± 19.78224
Temanogrel 40 mg
36.9000
± 14.94380
24 hours post-procedure/discharge
Group
Value
95% CI
Temanogrel 20 mg
NA
± NA
Concentration of AR295980Secondary· Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
Observed plasma concentration of AR295980.
Pre-PCI
Group
Value
95% CI
Temanogrel 20 mg
1.0472
± 0.87240
Temanogrel 40 mg
3.2010
± 3.97562
0 to 15 minutes post PCI
Group
Value
95% CI
Temanogrel 20 mg
6.3680
± 2.61560
Temanogrel 40 mg
6.8183
± 2.24211
1 hour post PCI
Group
Value
95% CI
Temanogrel 20 mg
5.0750
± 1.81783
Temanogrel 40 mg
8.0783
± 4.32397
3 hours post PCI
Group
Value
95% CI
Temanogrel 20 mg
3.6933
± 1.18230
Temanogrel 40 mg
5.5300
± 2.48489
6 hours post PCI
Group
Value
95% CI
Temanogrel 20 mg
2.4678
± 0.79325
Temanogrel 40 mg
5.2650
± 3.21979
24 hours post-PCI/discharge
Group
Value
95% CI
Temanogrel 20 mg
0.3518
± 0.40765
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of study treatment on Day 1 to up to maximum of 10 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 12 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04848220.