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

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ClinicalTrials.gov Identifier: NCT03114995
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : June 8, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Tae-Jin Youn, Seoul National University Bundang Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Non-ST Elevation Myocardial Infarction
Intervention Drug: Tirofiban
Enrollment 140
Recruitment Details 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
Pre-assignment Details  
Arm/Group Title Group A (High Platelet Reactivity - Tirofiban) Control C1 (High Platelet Reactivity - no Tirofiban) Control C2(Low Platelet Reactivity - no Tirofiban)
Hide Arm/Group Description

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

Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
Period Title: Overall Study
Started 31 31 78
Completed 30 30 78
Not Completed 1 1 0
Arm/Group Title Group A (High Platelet Reactivity - Tirofiban) Control C1 (High Platelet Reactivity - no Tirofiban) Control C2 (Low Platelet Reactivity - no Tirofiban) Total
Hide Arm/Group Description

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

Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered Total of all reporting groups
Overall Number of Baseline Participants 30 30 78 138
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 78 participants 138 participants
70.0  (12.8) 64.5  (12.0) 62.9  (10.1) 64.8  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 78 participants 138 participants
Female
13
  43.3%
5
  16.7%
11
  14.1%
29
  21.0%
Male
17
  56.7%
25
  83.3%
67
  85.9%
109
  79.0%
1.Primary Outcome
Title Area Under Curve of Serial Cardiac Biomarkers
Hide Description An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours
Time Frame 0,6,12,18,24,30,36 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (High Platelet Reactivity - Tirofiban) Control C1 (High Platelet Reactivity - no Tirofiban) Control C2 (Low Platelet Reactivity - no Tirofiban)
Hide Arm/Group Description:

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

Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered
Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
Overall Number of Participants Analyzed 30 30 78
Median (Inter-Quartile Range)
Unit of Measure: Hours*ng/ml
Troponin I
197.2
(41.5 to 395.7)
38.0
(8.9 to 313.9)
121.4
(43.7 to 481.8)
creatine kinase-MB isoenzyme
252.5
(48.0 to 470.1)
92.7
(39.1 to 402.1)
185.6
(79.8 to 425.3)
2.Secondary Outcome
Title Percentage of Participants With Periprocedural Myonecrosis
Hide Description

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.

Time Frame 0,6,12,18,24,30,36 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (High Platelet Reactivity - Tirofiban) Control C1 (High Platelet Reactivity - no Tirofiban) Control C2 (Low Platelet Reactivity - no Tirofiban)
Hide Arm/Group Description:

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

Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered
Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
Overall Number of Participants Analyzed 30 30 78
Measure Type: Count of Participants
Unit of Measure: Participants
Troponin I
16
  53.3%
15
  50.0%
26
  33.3%
creatine kinase-MB isoenzyme
11
  36.7%
10
  33.3%
25
  32.1%
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A (High Platelet Reactivity - Tirofiban) Control C1 (High Platelet Reactivity - no Tirofiban) Control C2 (Low Platelet Reactivity - no Tirofiban)
Hide Arm/Group Description

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

Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
All-Cause Mortality
Group A (High Platelet Reactivity - Tirofiban) Control C1 (High Platelet Reactivity - no Tirofiban) Control C2 (Low Platelet Reactivity - no Tirofiban)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/30 (6.67%)      0/30 (0.00%)      0/78 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group A (High Platelet Reactivity - Tirofiban) Control C1 (High Platelet Reactivity - no Tirofiban) Control C2 (Low Platelet Reactivity - no Tirofiban)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)      0/78 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A (High Platelet Reactivity - Tirofiban) Control C1 (High Platelet Reactivity - no Tirofiban) Control C2 (Low Platelet Reactivity - no Tirofiban)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/30 (13.33%)      1/30 (3.33%)      8/78 (10.26%)    
Blood and lymphatic system disorders       
Minor bleeding  [1]  4/30 (13.33%)  4 1/30 (3.33%)  1 8/78 (10.26%)  8
Indicates events were collected by systematic assessment
[1]
Minor bleeding defined by TIMI criteria
The difference in the distribution of PRU values of subjects estimated from previous literatures leading to small numbers of subjects assigned to the study group
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tae-Jin Youn
Organization: Cardiovascular Center, Seoul National University Bundang Hospital
Phone: +82-31-787-7031
EMail: ytjmd@snubh.org
Publications of Results:
Layout table for additonal information
Responsible Party: Tae-Jin Youn, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03114995     History of Changes
Other Study ID Numbers: B-1111-140-001
First Submitted: April 11, 2017
First Posted: April 14, 2017
Results First Submitted: May 8, 2018
Results First Posted: June 8, 2018
Last Update Posted: July 17, 2018