Trial Outcomes & Findings for Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI (NCT NCT00546260)

Last Updated: 2023-08-16

Results Overview

TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit. TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but \<5g/dL) or the hematocrit decreased by 10-15%. GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention. GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention. Stroke:New focal neurologic deficit that does not resolve within 24 hours.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

30 days

Results posted on

2023-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo Comparator	Experimental Experimental Cohorts (10, 20, 40, 60 mg)
Overall Study STARTED	36	34
Overall Study COMPLETED	28	32
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo Comparator	Experimental Experimental Cohorts (10, 20, 40, 60 mg)
Overall Study Drug not given pre diagnostic angiogr	8	2

Baseline Characteristics

Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=36 Participants Placebo Comparator	Experimental n=34 Participants Experimental Cohorts (10, 20, 40, 60 mg)	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	53.6 years STANDARD_DEVIATION 11.9 • n=5 Participants	57.8 years STANDARD_DEVIATION 10.4 • n=7 Participants	55.6 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All subjects receiving some component of study drug (the "as-treated" population)

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo Comparator	Experimental n=34 Participants Experimental Cohorts (10, 20, 40, 60 mg)
Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days Dose 10 mg	3 Participants	2 Participants
Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days Dose 20 mg	1 Participants	0 Participants
Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days Dose 40 mg	4 Participants	4 Participants
Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days Dose 60 mg	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Time for contrast to reach a standardized distal coronary landmark in the culprit vessel

Population: Per protocol

This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter.

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants Placebo Comparator	Experimental n=32 Participants Experimental Cohorts (10, 20, 40, 60 mg)
Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI Dose 10 mg	42 frames per minute Interval 13.0 to 100.0	59 frames per minute Interval 18.0 to 100.0
Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI Dose 20 mg	100 frames per minute Interval 24.0 to 100.0	100 frames per minute Interval 100.0 to 100.0
Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI Dose 40 mg	100 frames per minute Interval 100.0 to 100.0	100 frames per minute Interval 100.0 to 100.0
Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI Dose 60 mg	100 frames per minute Interval 100.0 to 100.0	100 frames per minute Interval 70.0 to 100.0

SECONDARY outcome

Timeframe: Before primary PCI

Population: Per protocol.

The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI.

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants Placebo Comparator	Experimental n=32 Participants Experimental Cohorts (10, 20, 40, 60 mg)
Percentage ST-segment Resolution Prior to PCI Dose 40 mg	75.3 Percentage of ST-segment Resolution Interval 62.8 to 100.0	37.9 Percentage of ST-segment Resolution Interval 13.3 to 66.3
Percentage ST-segment Resolution Prior to PCI Dose 10 mg	82.8 Percentage of ST-segment Resolution Interval 65.5 to 100.0	65 Percentage of ST-segment Resolution Interval 30.0 to 100.0
Percentage ST-segment Resolution Prior to PCI Dose 20 mg	72.4 Percentage of ST-segment Resolution Interval 27.1 to 83.0	86.5 Percentage of ST-segment Resolution Interval 63.2 to 100.0
Percentage ST-segment Resolution Prior to PCI Dose 60 mg	77.6 Percentage of ST-segment Resolution Interval 31.5 to 100.0	71.5 Percentage of ST-segment Resolution Interval 21.7 to 92.9

Adverse Events

Placebo

Serious events: 8 serious events

Other events: 15 other events

Deaths: 0 deaths

Experimental

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=36 participants at risk Placebo Comparator	Experimental n=34 participants at risk Experimental Cohorts (10, 20, 40, 60 mg)
Cardiac disorders Angina unstable	2.8% 1/36 • Number of events 1	0.00% 0/34
Cardiac disorders Cardiogenic shock	5.6% 2/36 • Number of events 2	0.00% 0/34
General disorders Chest pain	5.6% 2/36 • Number of events 2	0.00% 0/34
General disorders Vessel puncture site haemorrhage	2.8% 1/36 • Number of events 1	0.00% 0/34
Injury, poisoning and procedural complications Thrombosis in device	0.00% 0/36	2.9% 1/34 • Number of events 1
Metabolism and nutrition disorders Diabetes mellitus	2.8% 1/36 • Number of events 1	0.00% 0/34
Nervous system disorders Ischaemic stroke	0.00% 0/36	2.9% 1/34 • Number of events 1
Vascular disorders Peripheral artery dissection	2.8% 1/36 • Number of events 1	0.00% 0/34

Other adverse events

Other adverse events
Measure	Placebo n=36 participants at risk Placebo Comparator	Experimental n=34 participants at risk Experimental Cohorts (10, 20, 40, 60 mg)
Cardiac disorders Bradycardia	2.8% 1/36 • Number of events 1	5.9% 2/34 • Number of events 2
Cardiac disorders Ventricular tachycardia	8.3% 3/36 • Number of events 3	8.8% 3/34 • Number of events 3
Gastrointestinal disorders Nausea	0.00% 0/36	5.9% 2/34 • Number of events 2
General disorders Pyrexia	0.00% 0/36	5.9% 2/34 • Number of events 2
General disorders Vessel puncture site haematoma	2.8% 1/36 • Number of events 1	5.9% 2/34 • Number of events 2
General disorders Vessel puncture site pain	8.3% 3/36 • Number of events 3	0.00% 0/34
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/36	5.9% 2/34 • Number of events 2
Nervous system disorders Headache	2.8% 1/36 • Number of events 1	8.8% 3/34 • Number of events 3
Psychiatric disorders Insomnia	0.00% 0/36	5.9% 2/34 • Number of events 2
Vascular disorders Hypotension	16.7% 6/36 • Number of events 6	8.8% 3/34 • Number of events 3

Additional Information

Kevin Romanko, Senior Director Clinical Operations

Portola Pharmaceuticals Inc.

Phone: 650-246-7305

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. Additionally, individual publication may occur after coordinated multi-center publication.
Publication restrictions are in place

Restriction type: OTHER