Trial Outcomes & Findings for The Randomized OPTIMAL-ACT Trial (NCT NCT03772613)

NCT ID: NCT03772613

Last Updated: 2023-04-04

Results Overview

Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 180 participants
• Primary outcome timeframe: From date of randomization until the date of first documented bleeding event up to 24 hours
• Results posted on: 2023-04-04

Participant Flow

Participant milestones

Measure	Low ACT Target ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	Medium ACT Target ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	High ACT Target ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time
Overall Study STARTED	61	61	58
Overall Study COMPLETED	61	60	57
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Measure	Low ACT Target ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	Medium ACT Target ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	High ACT Target ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time
Overall Study Lost to Follow-up	0	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Low ACT Target n=61 Participants ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	Medium ACT Target n=61 Participants ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	High ACT Target n=58 Participants ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	Total n=180 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 12 • n=61 Participants	68 years STANDARD_DEVIATION 10 • n=61 Participants	67 years STANDARD_DEVIATION 10 • n=58 Participants	67 years STANDARD_DEVIATION 11 • n=180 Participants
Sex: Female, Male Female	19 Participants n=61 Participants	18 Participants n=61 Participants	14 Participants n=58 Participants	51 Participants n=180 Participants
Sex: Female, Male Male	42 Participants n=61 Participants	43 Participants n=61 Participants	44 Participants n=58 Participants	129 Participants n=180 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	61 participants n=61 Participants	61 participants n=61 Participants	58 participants n=58 Participants	180 participants n=180 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented bleeding event up to 24 hours

Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V)

Outcome measures

Measure	Low ACT Target n=61 Participants ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	Medium ACT Target n=60 Participants ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	High ACT Target n=57 Participants ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time
Bleeding	14 Participants	15 Participants	15 Participants

PRIMARY outcome

Timeframe: 30 days

Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding

Outcome measures

Measure	Low ACT Target n=61 Participants ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	Medium ACT Target n=60 Participants ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	High ACT Target n=57 Participants ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time
Adverse Clinical Events	2 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Number of subjects to experience stent thrombosis

Outcome measures

Measure	Low ACT Target n=61 Participants ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	Medium ACT Target n=60 Participants ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	High ACT Target n=57 Participants ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time
Stent Thrombosis	1 Participants	0 Participants	0 Participants

Adverse Events

Low ACT Target

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Medium ACT Target

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

High ACT Target

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low ACT Target n=61 participants at risk ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	Medium ACT Target n=61 participants at risk ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time	High ACT Target n=58 participants at risk ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time
Surgical and medical procedures Vessel Closure	0.00% 0/61 • Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.	1.6% 1/61 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.	3.4% 2/58 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.
Surgical and medical procedures Dissection	4.9% 3/61 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.	6.6% 4/61 • Number of events 4 • Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.	10.3% 6/58 • Number of events 6 • Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.
Surgical and medical procedures Spasm	1.6% 1/61 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.	0.00% 0/61 • Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.	0.00% 0/58 • Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.

Additional Information

Dr. Shahyar M. Gharacholou

Mayo Clinic

Phone: 904-956-8400

Email: Gharacholou.Shahyar@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place