Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02925923
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

Patients with troponin-negative acute coronary syndrome (ACS) are not routinely pre-treated with P2Y12 inhibitors and the rate of high on-treatment platelet reactivity (HPR) remains elevated after a loading dose of ticagrelor at the time of percutaneous coronary intervention (PCI). This suggests that faster platelet inhibition with crushed ticagrelor , eptifibatide , or cangrelor is needed to reduce HPR and periprocedural myocardial infarction and injury (PMI). The present study compared the effects of crushed ticagrelor vs. eptifibatide bolus + clopidogrel in troponin-negative ACS patients undergoing PCI.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Angina, Unstable	Drug: Ticagrelor; Drug: Eptifibatide; Drug: Clopidogrel	Phase 2

Detailed Description

Platelet activation and accumulation causes the formation of blood clots that may cause heart attack. As a standard of care, the doctor can prescribe medications such as are ticagrelor, eptifibatide, clopidogrel, to prevent the formation of blood clots.

100 patients with unstable angina, both male and female, will be randomized to either Group A- Crushed Ticagrelor or Group B- Eptifibatide bolus +Clopidogrel administrated immediately before PCI. Platelet function testing, troponin, and ECG will be performed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effects of Crushed Ticagrelor Versus Eptifibatide Bolus +Clopidogrel in Troponin-Negative ACS Patients Undergoing Coronary Intervention
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Jan 30, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ticagrelor crushed ticagrelor (180 mg); (n=50 patients)	Drug: Ticagrelor; After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.; Other Names: Brilinta
Active Comparator: Eptifibatide bolus+clopidogrel Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)	Drug: Eptifibatide; After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.; Other Names: Integrilin ; Drug: Clopidogrel; Other Names: Plavix

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR) [5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)]

   We assessed platelet aggregation at baseline and during PCI by light transmission aggregomerty. The primary efficacy measure was HPR defined as platelet aggregation >59% at 2 h measured by the Chronlog aggregometer after stimulation with ADP 20 µM.

Secondary Outcome Measures

1. Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI) [At baseline and every 8 hours post- PCI]

   The rate of PMI will be compared in patients randomized to crushed ticagrelor vs. eptifibatide bolus +clopidogrel

2. Platelet Aggregation Levels [At baseline and at 0.5, 2, 4, and 24 hours after loading dose]

   The rates of platelet aggregation with ADP and TRAP will be measured in patients randomized to crushed ticagrelor vs. eptifibatide bolus+clopidogrel

3. Change in Hemoglobin Levels (g/dL) [At baseline and at 24 hours post-PCI]

   Hemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI.

4. A Change in Hematocrit Levels [At baseline and at 24 hours post-PCI]

   Hematocrit levels (%) will be measured at baseline and on the next day after PCI.

5. Heparin Dose, Unit/Kg [24 hours after the PCI]

   For the heparin dose range for the two groups would have a minimum dose of 4693 and a maximum dose of 11141 units per kilogram.The higher the number is indicative that a higher dose of heparin is needed based on kilogram weight.

6. Activated Clotting Time (ACT), Seconds [At the end of PCI]

   The Level of the highest ACT during PCI will be compared between the groups

7. Number of Patients With Minor Bleeding Complications [At 24 hours post-PCI]

   We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL.

8. Number of Patients With Minor Bleeding Complications [At 1 year post-PCI]

   We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL.

9. Number of Patients With Major Bleeding Complications [At 24 hours post-PCI]

   We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage.

10. Number of Patients With Major Bleeding Complications [At 1 year post-PCI]

    We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage.

11. Number of Patients With Negative Clinical Outcomes [At 1-year post-PCI]

    The rates of death, myocardial infarction, and revascularization at 1-year post-PCI.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with unstable angina/troponin negative ACS.

Exclusion Criteria:

1. need for oral anticoagulation therapy (Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban)

2. increased risk of bradycardia, and the associated therapy with a strong cytochrome P-450 inhibitors (anti-retroviral agents, antifungal agents and some antibiotics eg. Indinavir, Nelfinavir, Lopinavir, Ritonavir, Itraconazole, Ketoconazole, Voriconazole, Clarithromycin, Telithormycin)

3. surgery<4 weeks

4. use of any thienopyridines (Clopidogrel, Prasugrel) 7 days prior to randomization

5. administration of GP IIb/IIIa inhibitors

6. bleeding diathesis or major bleeding episode within 2 weeks

7. thrombocytopenia (Platelet count < 100000)

8. incessant chest pain

9. hemodynamic instability (Mean arterial pressure < 65 mm Hg; need for vasopressor or inotropic agents; need for mechanical circulatory support for coronary intervention), NSTEMI as evidenced by elevation of troponin levels (Troponin > 0.034 ng/ml); renal failure with a serum creatinine >2.0 mg/dL

10. anemia with HCT<30%.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Massoud Leesar, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 17, 2019

More Information

Publications

None provided.

• Responsible Party: Massoud Leesar, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02925923
• Other Study ID Numbers: F151006002
• First Posted: Oct 6, 2016
• Last Update Posted: May 4, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Acute Coronary Syndrome; Angina, Unstable; Clopidogrel; Ticagrelor; Eptifibatide

Study Results

Participant Flow

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Period Title: Overall Study
STARTED	50	50
COMPLETED	50	48
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel	Total
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel	Total of all reporting groups
Overall Participants	50	50	100
Age, Customized (participants) [Number]
>=19 years	50 100%	50 100%	100 100%
Sex: Female, Male (Count of Participants)
Female	19 38%	12 24%	31 31%
Male	31 62%	38 76%	69 69%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
Description	We assessed platelet aggregation at baseline and during PCI by light transmission aggregomerty. The primary efficacy measure was HPR defined as platelet aggregation >59% at 2 h measured by the Chronlog aggregometer after stimulation with ADP 20 µM.
Time Frame	5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)

Outcome Measure Data

Analysis Population Description

2 participants of the Eptifibatide Bolus+Clopidogrel arm were unable to be analyzed due to blood samples being hemolyzed

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	48
Baseline (n-50, n-48)	37 74%	33 66%
0.5 h (n-50, n-48)	24 48%	0 0%
2 h (n-50, n-48)	6 12%	0 0%
4 h (n-50, n-48)	0 0%	0 0%
24 h (n-50, n-48)	2 4%	5 10%

2. Secondary Outcome

Title	Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI)
Description	The rate of PMI will be compared in patients randomized to crushed ticagrelor vs. eptifibatide bolus +clopidogrel
Time Frame	At baseline and every 8 hours post- PCI

Outcome Measure Data

Analysis Population Description

2 participants of the Eptifibatide Bolus+Clopidogrel arm were unable to be analyzed due to blood samples being hemolyzed

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Count of Participants [Participants]	24 48%	14 28%

3. Secondary Outcome

Title	Platelet Aggregation Levels
Description	The rates of platelet aggregation with ADP and TRAP will be measured in patients randomized to crushed ticagrelor vs. eptifibatide bolus+clopidogrel
Time Frame	At baseline and at 0.5, 2, 4, and 24 hours after loading dose

Outcome Measure Data

Analysis Population Description

We did not have enough plasma sample to measure TRAP 10 at 4, 24 h.

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	48
Baseline (ADP 20)	65 (14)	62 (10)
0.5 h (ADP 20)	53 (12)	1.3 (2)
2 h (ADP 20)	35 (11)	.34 (1)
4 h (ADP 20)	23 (9)	3.5 (2)
24 h (ADP 20)	25 (10)	38 (9)
Baseline (ADP 5)	56 (12)	54 (13)
0.5 h (ADP 5)	44 (17)	1.18 (4)
2 h (ADP 5)	24 (13)	.3 (.93)
4 h (ADP 5)	15 (9)	1.6 (1.5)
24 h (ADP 5)	18 (14)	27 (17)
Baseline (TRAP 20)	68 (14)	67 (16)
0.5 h (TRAP 20)	60 (13)	3.9 (3.6)
2 h (TRAP 20)	51 (8)	6 (5)
4 h (TRAP 20)	48 (12)	14 (10)
24 h (TRAP 20)	54 (11)	51 (11)
Baseline (TRAP 10)	56 (18)	54 (19)
0.5 h (TRAP 10)	48 (19)	1.18 (1)
2 h (TRAP 10)	37 (17)	1.57 (2)

4. Secondary Outcome

Title	Change in Hemoglobin Levels (g/dL)
Description	Hemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI.
Time Frame	At baseline and at 24 hours post-PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Baseline (hemoglobin, g/dL)	13.52 (2)	13.34 (1.62)
Post-PCI (hemoglobin, g/dL)	12.73 (1.81)	12.71 (1.6)

5. Secondary Outcome

Title	A Change in Hematocrit Levels
Description	Hematocrit levels (%) will be measured at baseline and on the next day after PCI.
Time Frame	At baseline and at 24 hours post-PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Baseline (hematocrit, %)	40.11 (5.36)	40.02 (4.49)
Post-PCI (hematocrit, %)	37.68 (4.85)	37.5 (4.2)

6. Secondary Outcome

Title	Heparin Dose, Unit/Kg
Description	For the heparin dose range for the two groups would have a minimum dose of 4693 and a maximum dose of 11141 units per kilogram.The higher the number is indicative that a higher dose of heparin is needed based on kilogram weight.
Time Frame	24 hours after the PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Mean (Standard Deviation) [units per kilogram]	8854 (2287)	6021 (1328)

7. Secondary Outcome

Title	Activated Clotting Time (ACT), Seconds
Description	The Level of the highest ACT during PCI will be compared between the groups
Time Frame	At the end of PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Mean (Standard Deviation) [s]	332 (48)	278 (47)

8. Secondary Outcome

Title	Number of Patients With Minor Bleeding Complications
Description	We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL.
Time Frame	At 24 hours post-PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Count of Participants [Participants]	0 0%	0 0%

9. Secondary Outcome

Title	Number of Patients With Minor Bleeding Complications
Description	We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL.
Time Frame	At 1 year post-PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Count of Participants [Participants]	0 0%	0 0%

10. Secondary Outcome

Title	Number of Patients With Major Bleeding Complications
Description	We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage.
Time Frame	At 24 hours post-PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Count of Participants [Participants]	0 0%	0 0%

11. Secondary Outcome

Title	Number of Patients With Major Bleeding Complications
Description	We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage.
Time Frame	At 1 year post-PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Count of Participants [Participants]	0 0%	0 0%

12. Secondary Outcome

Title	Number of Patients With Negative Clinical Outcomes
Description	The rates of death, myocardial infarction, and revascularization at 1-year post-PCI.
Time Frame	At 1-year post-PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ticagrelor	Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.	Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
Measure Participants	50	50
Death	2 4%	0 0%
Myocardial infarction	0 0%	0 0%
Revascularization	1 2%	0 0%

Adverse Events

Time Frame	4 weeks post-discharge
Arm/Group Title	Ticagrelor		Eptifibatide Bolus+Clopidogrel
Arm/Group Description	crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.		Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel
All Cause Mortality
	Ticagrelor		Eptifibatide Bolus+Clopidogrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/50 (4%)		0/50 (0%)
Serious Adverse Events
	Ticagrelor		Eptifibatide Bolus+Clopidogrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/50 (2%)		0/50 (0%)
Cardiac disorders
Target Lesion Revascularization (TLR)	1/50 (2%)	1	0/50 (0%)	0
Other (Not Including Serious) Adverse Events
	Ticagrelor		Eptifibatide Bolus+Clopidogrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.