Trial Outcomes & Findings for Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients (NCT NCT03114995)

Results Overview

An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

140 participants

Primary outcome timeframe

0,6,12,18,24,30,36 hours

Results posted on

2018-07-17

Participant Flow

Consecutively enrolled patients who are already stabilized with standard medical treatment and diagnosed with Non-ST elevation acute coronary syndrome (NSTE-ACS) at Seoul National University Bundang Hospital from February 2012 to October 2015

Participant milestones

Participant milestones
Measure	Group A (High Platelet Reactivity - Tirofiban) Patients with high platelet reactivity (HPR) unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h Tirofiban	Control C1 (High Platelet Reactivity - no Tirofiban) Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered	Control C2(Low Platelet Reactivity - no Tirofiban) Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
Overall Study STARTED	31	31	78
Overall Study COMPLETED	30	30	78
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A (High Platelet Reactivity - Tirofiban) n=30 Participants Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h Tirofiban	Control C1 (High Platelet Reactivity - no Tirofiban) n=30 Participants Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered	Control C2 (Low Platelet Reactivity - no Tirofiban) n=78 Participants Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered	Total n=138 Participants Total of all reporting groups
Age, Continuous	70.0 years STANDARD_DEVIATION 12.8 • n=5 Participants	64.5 years STANDARD_DEVIATION 12.0 • n=7 Participants	62.9 years STANDARD_DEVIATION 10.1 • n=5 Participants	64.8 years STANDARD_DEVIATION 11.4 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	25 Participants n=7 Participants	67 Participants n=5 Participants	109 Participants n=4 Participants

PRIMARY outcome

Timeframe: 0,6,12,18,24,30,36 hours

An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours

Outcome measures

Outcome measures
Measure	Group A (High Platelet Reactivity - Tirofiban) n=30 Participants Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h Tirofiban	Control C1 (High Platelet Reactivity - no Tirofiban) n=30 Participants Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered	Control C2 (Low Platelet Reactivity - no Tirofiban) n=78 Participants Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
Area Under Curve of Serial Cardiac Biomarkers Troponin I	197.2 Hours*ng/ml Interval 41.5 to 395.7	38.0 Hours*ng/ml Interval 8.9 to 313.9	121.4 Hours*ng/ml Interval 43.7 to 481.8
Area Under Curve of Serial Cardiac Biomarkers creatine kinase-MB isoenzyme	252.5 Hours*ng/ml Interval 48.0 to 470.1	92.7 Hours*ng/ml Interval 39.1 to 402.1	185.6 Hours*ng/ml Interval 79.8 to 425.3

SECONDARY outcome

Timeframe: 0,6,12,18,24,30,36 hours

Percentage of participants with periprocedural myonecrosis under the criteria described below. When the cardiac biomarkers before the procedure were within the 99th percentile upper reference limit (URL), more than a 5-fold elevation in the URL within 12 hours after percutaneous coronary intervention (PCI) was defined as periprocedural myonecrosis. If the cardiac biomarker level was already above the 99th percentile URL before the procedure and the trend was stationary or decreasing, a ≥20% increase compared to the previous level was considered periprocedural myonecrosis. If the trend was still increasing, the levels at the post-6 hour and 12-hour were compared to determine periprocedural myonecrosis.

Outcome measures

Outcome measures
Measure	Group A (High Platelet Reactivity - Tirofiban) n=30 Participants Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h Tirofiban	Control C1 (High Platelet Reactivity - no Tirofiban) n=30 Participants Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered	Control C2 (Low Platelet Reactivity - no Tirofiban) n=78 Participants Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
Percentage of Participants With Periprocedural Myonecrosis Troponin I	16 Participants	15 Participants	26 Participants
Percentage of Participants With Periprocedural Myonecrosis creatine kinase-MB isoenzyme	11 Participants	10 Participants	25 Participants

Adverse Events

Group A (High Platelet Reactivity - Tirofiban)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 2 deaths

Control C1 (High Platelet Reactivity - no Tirofiban)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control C2 (Low Platelet Reactivity - no Tirofiban)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group A (High Platelet Reactivity - Tirofiban) n=30 participants at risk Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h Tirofiban	Control C1 (High Platelet Reactivity - no Tirofiban) n=30 participants at risk Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered	Control C2 (Low Platelet Reactivity - no Tirofiban) n=78 participants at risk Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
Blood and lymphatic system disorders Minor bleeding	13.3% 4/30 • Number of events 4 • 1 month	3.3% 1/30 • Number of events 1 • 1 month	10.3% 8/78 • Number of events 8 • 1 month

Additional Information

Dr. Tae-Jin Youn

Cardiovascular Center, Seoul National University Bundang Hospital

Phone: +82-31-787-7031

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place