Trial Outcomes & Findings for Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel (NCT NCT02925923)
NCT ID: NCT02925923
Last Updated: 2020-05-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)
Results posted on
2020-05-04
Participant Flow
Participant milestones
| Measure |
Ticagrelor
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+Clopidogrel
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
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Ticagrelor
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+Clopidogrel
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
|
|---|---|---|
|
Overall Study
blood samples hemolyzed
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=19 years
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
31 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=50 Participants
|
38 Participants
n=50 Participants
|
69 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)Population: 2 participants of the Eptifibatide Bolus+Clopidogrel arm were unable to be analyzed due to blood samples being hemolyzed
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.
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=48 Participants
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
|
|---|---|---|
|
Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
Baseline (n-50, n-48)
|
37 count of participants
|
33 count of participants
|
|
Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
0.5 h (n-50, n-48)
|
24 count of participants
|
0 count of participants
|
|
Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
2 h (n-50, n-48)
|
6 count of participants
|
0 count of participants
|
|
Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
4 h (n-50, n-48)
|
0 count of participants
|
0 count of participants
|
|
Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
24 h (n-50, n-48)
|
2 count of participants
|
5 count of participants
|
SECONDARY outcome
Timeframe: At baseline and every 8 hours post- PCIPopulation: 2 participants of the Eptifibatide Bolus+Clopidogrel arm were unable to be analyzed due to blood samples being hemolyzed
The rate of PMI will be compared in patients randomized to crushed ticagrelor vs. eptifibatide bolus +clopidogrel
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI)
|
24 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: At baseline and at 0.5, 2, 4, and 24 hours after loading dosePopulation: We did not have enough plasma sample to measure TRAP 10 at 4, 24 h.
The rates of platelet aggregation with ADP and TRAP will be measured in patients randomized to crushed ticagrelor vs. eptifibatide bolus+clopidogrel
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=48 Participants
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
|
|---|---|---|
|
Platelet Aggregation Levels
24 h (TRAP 20)
|
54 μmol/L
Standard Deviation 11
|
51 μmol/L
Standard Deviation 11
|
|
Platelet Aggregation Levels
Baseline (ADP 20)
|
65 μmol/L
Standard Deviation 14
|
62 μmol/L
Standard Deviation 10
|
|
Platelet Aggregation Levels
0.5 h (ADP 20)
|
53 μmol/L
Standard Deviation 12
|
1.3 μmol/L
Standard Deviation 2
|
|
Platelet Aggregation Levels
2 h (ADP 20)
|
35 μmol/L
Standard Deviation 11
|
.34 μmol/L
Standard Deviation 1
|
|
Platelet Aggregation Levels
4 h (ADP 20)
|
23 μmol/L
Standard Deviation 9
|
3.5 μmol/L
Standard Deviation 2
|
|
Platelet Aggregation Levels
24 h (ADP 20)
|
25 μmol/L
Standard Deviation 10
|
38 μmol/L
Standard Deviation 9
|
|
Platelet Aggregation Levels
Baseline (ADP 5)
|
56 μmol/L
Standard Deviation 12
|
54 μmol/L
Standard Deviation 13
|
|
Platelet Aggregation Levels
0.5 h (ADP 5)
|
44 μmol/L
Standard Deviation 17
|
1.18 μmol/L
Standard Deviation 4
|
|
Platelet Aggregation Levels
2 h (ADP 5)
|
24 μmol/L
Standard Deviation 13
|
.3 μmol/L
Standard Deviation .93
|
|
Platelet Aggregation Levels
4 h (ADP 5)
|
15 μmol/L
Standard Deviation 9
|
1.6 μmol/L
Standard Deviation 1.5
|
|
Platelet Aggregation Levels
24 h (ADP 5)
|
18 μmol/L
Standard Deviation 14
|
27 μmol/L
Standard Deviation 17
|
|
Platelet Aggregation Levels
Baseline (TRAP 20)
|
68 μmol/L
Standard Deviation 14
|
67 μmol/L
Standard Deviation 16
|
|
Platelet Aggregation Levels
0.5 h (TRAP 20)
|
60 μmol/L
Standard Deviation 13
|
3.9 μmol/L
Standard Deviation 3.6
|
|
Platelet Aggregation Levels
2 h (TRAP 20)
|
51 μmol/L
Standard Deviation 8
|
6 μmol/L
Standard Deviation 5
|
|
Platelet Aggregation Levels
4 h (TRAP 20)
|
48 μmol/L
Standard Deviation 12
|
14 μmol/L
Standard Deviation 10
|
|
Platelet Aggregation Levels
Baseline (TRAP 10)
|
56 μmol/L
Standard Deviation 18
|
54 μmol/L
Standard Deviation 19
|
|
Platelet Aggregation Levels
0.5 h (TRAP 10)
|
48 μmol/L
Standard Deviation 19
|
1.18 μmol/L
Standard Deviation 1
|
|
Platelet Aggregation Levels
2 h (TRAP 10)
|
37 μmol/L
Standard Deviation 17
|
1.57 μmol/L
Standard Deviation 2
|
SECONDARY outcome
Timeframe: At baseline and at 24 hours post-PCIHemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI.
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
Change in Hemoglobin Levels (g/dL)
Baseline (hemoglobin, g/dL)
|
13.52 g/dL
Standard Deviation 2
|
13.34 g/dL
Standard Deviation 1.62
|
|
Change in Hemoglobin Levels (g/dL)
Post-PCI (hemoglobin, g/dL)
|
12.73 g/dL
Standard Deviation 1.81
|
12.71 g/dL
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: At baseline and at 24 hours post-PCIHematocrit levels (%) will be measured at baseline and on the next day after PCI.
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
A Change in Hematocrit Levels
Baseline (hematocrit, %)
|
40.11 hematocrit (%)
Standard Deviation 5.36
|
40.02 hematocrit (%)
Standard Deviation 4.49
|
|
A Change in Hematocrit Levels
Post-PCI (hematocrit, %)
|
37.68 hematocrit (%)
Standard Deviation 4.85
|
37.5 hematocrit (%)
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 24 hours after the PCIFor 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.
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
Heparin Dose, Unit/Kg
|
8854 units per kilogram
Standard Deviation 2287
|
6021 units per kilogram
Standard Deviation 1328
|
SECONDARY outcome
Timeframe: At the end of PCIThe Level of the highest ACT during PCI will be compared between the groups
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
Activated Clotting Time (ACT), Seconds
|
332 s
Standard Deviation 48
|
278 s
Standard Deviation 47
|
SECONDARY outcome
Timeframe: At 24 hours post-PCIWe 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.
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
Number of Patients With Minor Bleeding Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 1 year post-PCIWe 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.
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
Number of Patients With Minor Bleeding Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 24 hours post-PCIWe 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.
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
Number of Patients With Major Bleeding Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 1 year post-PCIWe 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.
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
Number of Patients With Major Bleeding Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 1-year post-PCIThe rates of death, myocardial infarction, and revascularization at 1-year post-PCI.
Outcome measures
| Measure |
Ticagrelor
n=50 Participants
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+Clopidogrel
n=50 Participants
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
|
|---|---|---|
|
Number of Patients With Negative Clinical Outcomes
Revascularization
|
1 Participants
|
0 Participants
|
|
Number of Patients With Negative Clinical Outcomes
Death
|
2 Participants
|
0 Participants
|
|
Number of Patients With Negative Clinical Outcomes
Myocardial infarction
|
0 Participants
|
0 Participants
|
Adverse Events
Ticagrelor
Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths
Eptifibatide Bolus+Clopidogrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ticagrelor
n=50 participants at risk
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+Clopidogrel
n=50 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Target Lesion Revascularization (TLR)
|
2.0%
1/50 • Number of events 1 • 4 weeks post-discharge
|
0.00%
0/50 • 4 weeks post-discharge
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place