Trial Outcomes & Findings for Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization (NCT NCT00178620)

NCT ID: NCT00178620

Last Updated: 2023-09-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 390 participants
• Primary outcome timeframe: 30 day
• Results posted on: 2023-09-06

Participant Flow

All ACS patients 18 years or older with documented STEMI on EKG, who presented within 6 hours of onset of sustained chest pain, and met all eligibility criteria, were enrolled in PATCAR after an informed consent was obtained.

Participant milestones

Measure	Group A Full dose, pre-hospital fibrinolysis followed by treatment in the coronary care unit	Group B One-half dose pre-hospital reteplase followed by urgent PCI	Group C Fibrinolytic ineligible patients, treated with primary PCI at the STEMI center	Group D Patients not transported by participating EMS units but were transferred in and treated with primary PCI at the STEMI center
Overall Study STARTED	37	253	37	63
Overall Study COMPLETED	37	253	37	63
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization

Baseline characteristics by cohort

Measure	Group A n=37 Participants Full dose, pre-hospital fibrinolysis followed by treatment in the coronary care unit.	Group B n=253 Participants One-half dose pre-hospital reteplase followed by urgent PCI	Group C n=37 Participants Fibrinolytic ineligible patients who were treated with primary PCI at the STEMI center.	Group D n=63 Participants Patients not transported by participating EMS units transferred in and treated with primary PCI at the STEMI center.	Total n=390 Participants Total of all reporting groups
Age, Customized <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Age, Customized Between 18 and 65 years	37 participants n=5 Participants	253 participants n=7 Participants	37 participants n=5 Participants	63 participants n=4 Participants	390 participants n=21 Participants
Age, Customized >=65 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	69 Participants n=7 Participants	17 Participants n=5 Participants	14 Participants n=4 Participants	106 Participants n=21 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	184 Participants n=7 Participants	20 Participants n=5 Participants	49 Participants n=4 Participants	284 Participants n=21 Participants
Treatment Allocation by Group	37 participants n=5 Participants	253 participants n=7 Participants	37 participants n=5 Participants	63 participants n=4 Participants	390 participants n=21 Participants

PRIMARY outcome

Timeframe: 30 day

Outcome measures

Measure	Group A n=37 Participants Full does, pre-hospital fibrinolysis followed by treatment in the coronary care unit.	Group B n=253 Participants One-half dose pre-hospital reteplase followed by urgent PCI	Group C n=37 Participants Fibrinolytic ineligible patients who were treated with primary PCI at the STEMI center.	Group D n=63 Participants Patients not transported by participating EMS units transferred in and treated with primary PCI at the STEMI center.
Mortality at 30 Days	1 participants	7 participants	3 participants	2 participants

SECONDARY outcome

Timeframe: 1 year

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Group D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group A n=37 participants at risk Full dose, pre-hospital fibrinolysis followed by treatment in the coronary care unit	Group B n=253 participants at risk One-half dose pre-hospital reteplase followed by urgent PCI	Group C n=37 participants at risk Fibrinolytic ineligible patients, treated with primary PCI at the STEMI center	Group D n=63 participants at risk Patients not transported by participating EMS units but were transferred in and treated with primary PCI at the STEMI center
Cardiac disorders Death	0.00% 0/37	3.6% 9/253 • Number of events 9	10.8% 4/37 • Number of events 4	0.00% 0/63

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard W. Smalling

The University of Texas Health Science Center at Houston

Phone: 713-500-6559

Email: richard.w.smalling@uth.tmc.edu

Results disclosure agreements

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