Trial Outcomes & Findings for Targeting Platelets in Chronic HIV Infection (NCT NCT02578706)

NCT ID: NCT02578706

Last Updated: 2018-02-28

Results Overview

Soluble CD14 (sCD14) levels in blood. sCD14 is a nonspecific maker of monocyte activation.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: baseline and 24 weeks
• Results posted on: 2018-02-28

Participant Flow

Participant milestones

Measure	Aspirin and Placebo At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Overall Study STARTED	9	10	8
Overall Study COMPLETED	8	5	8
Overall Study NOT COMPLETED	1	5	0

Reasons for withdrawal

Measure	Aspirin and Placebo At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Overall Study Withdrawal by Subject	1	0	0
Overall Study Lost to Follow-up	0	4	0
Overall Study Physician Decision	0	1	0

Baseline Characteristics

Targeting Platelets in Chronic HIV Infection

Baseline characteristics by cohort

Measure	Aspirin and Placebo n=9 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=10 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Total n=27 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 11.9 • n=5 Participants	44.2 years STANDARD_DEVIATION 8.3 • n=7 Participants	50.75 years STANDARD_DEVIATION 11.7 • n=5 Participants	46.4 years STANDARD_DEVIATION 10.6 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline and 24 weeks

Soluble CD14 (sCD14) levels in blood. sCD14 is a nonspecific maker of monocyte activation.

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in sCD14 From Baseline to Week 24	35.75 pg/mL Standard Deviation 231.87	-251.40 pg/mL Standard Deviation 201.33	-101.75 pg/mL Standard Deviation 339.34

SECONDARY outcome

Timeframe: 24 weeks

Safety as measured by a Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality. A grade 3 sign/symptom was defined as medically significant but not immediately life threatening.

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Number of Subjects With at Least One Grade 3 or Higher Sign/Symptom or Laboratory Abnormality	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: baseline and 24 weeks

The classical monocyte is characterized by high level expression of the CD14 cell surface receptor (CD14++ CD16- monocyte)

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Classical Monocyte Subsets From Baseline to Week 24	-0.09 10^3 cells/µl Standard Deviation 0.13	-0.12 10^3 cells/µl Standard Deviation 0.19	-0.04 10^3 cells/µl Standard Deviation 0.20

SECONDARY outcome

Timeframe: Baseline and 24 weeks

The intermediate monocyte with high level expression of CD14 and low level expression of CD16 (CD14++CD16+ monocytes).

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Intermediate Monocyte Subsets From Baseline to Week 24.	0.02 10^3 cells/µl Standard Deviation 0.18	0.06 10^3 cells/µl Standard Deviation 0.19	0.04 10^3 cells/µl Standard Deviation 0.18

SECONDARY outcome

Timeframe: baseline and 24 weeks

The non-classical monocyte shows low level expression of CD14 and additional co-expression of the CD16 receptor (CD14+CD16++ monocyte).[

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Non-classical Monocyte Subsets From Baseline to Week 24	0.002 10^3 cells/µl Standard Deviation 0.04	0.03 10^3 cells/µl Standard Deviation 0.05	-0.03 10^3 cells/µl Standard Deviation 0.11

SECONDARY outcome

Timeframe: baseline and 24 weeks

Soluble CD163 is a specific macrophage activation marker, associated with morphological disease grade. A high sCD163 indicates more disease.

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Monocyte Activation sCD163 From Baseline to Week 24	26.88 10^3 cells/µl Standard Deviation 137.06	15.8 10^3 cells/µl Standard Deviation 102.24	-63.38 10^3 cells/µl Standard Deviation 138.19

SECONDARY outcome

Timeframe: baseline and 24 weeks

Interleukin 6 gene encodes a cytokine that functions in inflammation and implicated in a variety of inflammatory-associated disease states.

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in IL-6 From Baseline to Week 24	-0.36 pg/mL Standard Deviation 1.01	0.02 pg/mL Standard Deviation 4.08	0.85 pg/mL Standard Deviation 2.61

SECONDARY outcome

Timeframe: Baseline and 24 weeks

D-Dimer level looks at coagulation of blood. D-dimers are not normally present in blood except when coagulation has occurred.

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in D-dimer From Baseline to Week 24	-295.99 mcg/L Standard Deviation 1898.66	151.96 mcg/L Standard Deviation 721.59	1109.38 mcg/L Standard Deviation 2664.77

SECONDARY outcome

Timeframe: baseline and 24 weeks

Soluble tumor necrosis factor receptor (sTNFR) serum concentration

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in sTNFR I From Baseline to Week 24	137.77 pg/ml Standard Deviation 262.09	59.46 pg/ml Standard Deviation 38.18	19.78 pg/ml Standard Deviation 98.66

SECONDARY outcome

Timeframe: baseline and 24 weeks

Soluble tumor necrosis factor receptor (sTNFR) serum concentration

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in sTNFR II From Baseline to Week 24	283.13 pg/ml Standard Deviation 444.62	347.00 pg/ml Standard Deviation 1103.85	4.25 pg/ml Standard Deviation 486.28

SECONDARY outcome

Timeframe: baseline and 24 weeks

Soluble CD40-ligand levels

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in sCD40L From Baseline to Week 24	-28.05 pg/mL Standard Deviation 147.34	-25.68 pg/mL Standard Deviation 188.83	13.65 pg/mL Standard Deviation 106.45

SECONDARY outcome

Timeframe: baseline and 24 weeks

Change in % platelet aggregation in response to stimulation by Adenosine Diphosphate (ADP) from baseline to week 24

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Platelet Aggregometry in Response to ADP 20µM From Baseline to Week 24	-7.25 % platelet aggregation Standard Deviation 8.06	-32.40 % platelet aggregation Standard Deviation 25.41	-6.50 % platelet aggregation Standard Deviation 10.61

SECONDARY outcome

Timeframe: baseline and 24 weeks

Change in % platelet aggregation in response to stimulation by Collagen 2µg/mL from baseline to week 24

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Platelet Aggregometry in Response to Collagen 2µg/mL From Baseline to Week 24	-40.37 % platelet aggregation Standard Deviation 26.70	-9.60 % platelet aggregation Standard Deviation 14.69	8.62 % platelet aggregation Standard Deviation 21.20

SECONDARY outcome

Timeframe: baseline and 24 weeks

Change in % platelet aggregation in response to stimulation by light transmission aggregometry as measured by epinephrine 5µM from baseline to week 24

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Platelet Aggregometry in Response to Epi 5µM From Baseline to Week 24	-35.25 % platelet aggregation Standard Deviation 31.56	-21.40 % platelet aggregation Standard Deviation 42.02	-10.63 % platelet aggregation Standard Deviation 32.07

SECONDARY outcome

Timeframe: baseline and 24 weeks

Change in spontaneous % platelet from baseline to week 24. Spontaneous platelet aggregation?

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Spontaneous Platelet Aggregometry From Baseline to Week 24	-0.75 % platelet Standard Deviation 1.28	-0.60 % platelet Standard Deviation 2.19	-0.88 % platelet Standard Deviation 2.23

SECONDARY outcome

Timeframe: baseline and 24 weeks

Change in % platelet aggregation in response to stimulation by arachidonic acid 1500µM from baseline to week 24

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Platelet Aggregometry in Response to Arachidonic Acid 1500µM From Baseline to Week 24	-53.33 % platelet aggregation Standard Deviation 41.91	-31.00 % platelet aggregation Standard Deviation 0	-13.25 % platelet aggregation Standard Deviation 35.88

SECONDARY outcome

Timeframe: baseline and 24 weeks

Change in % platelet monocyte aggregates from baseline to week 24

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Monocyte Platelet Aggregates From Baseline to 24 Weeks	10.55 % platelet monocyte aggregates Standard Deviation 16.41	3.88 % platelet monocyte aggregates Standard Deviation 12.02	8.96 % platelet monocyte aggregates Standard Deviation 24.59

SECONDARY outcome

Timeframe: baseline and 24 weeks

Clot formation kinetics, or coagulation time, is measured using thromboelastography. time to 2mm amplitude in seconds.

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Coagulation Time (CT) From Baseline to 24 Weeks	3.00 seconds Standard Deviation 23.30	1.00 seconds Standard Deviation 24.30	-13.13 seconds Standard Deviation 33.75

SECONDARY outcome

Timeframe: baseline and 24 weeks

Clot formation time is measured using thromboelastography. time from 2 to 20 mm amplitude in seconds.

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Clot Formation Time (CFT) From Baseline to 24 Weeks	-1.00 seconds Standard Deviation 7.58	2.00 seconds Standard Deviation 4.69	1.63 seconds Standard Deviation 15.62

SECONDARY outcome

Timeframe: baseline and 24 weeks

Maximum Clot Firmness (MCF) is measured using thromboelastography. maximum ampliture in mm

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Maximum Clot Firmness (MCF) From Baseline to 24 Weeks	1.38 mm Standard Deviation 1.69	1.20 mm Standard Deviation 2.77	0.38 mm Standard Deviation 4.47

SECONDARY outcome

Timeframe: baseline and 24 weeks

Alpha angle is measured using thromboelastography, measured by a tangent to the clotting curve through the 2mm point

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Alpha Angle From Baseline to 24 Weeks	0.00 degree Standard Deviation 1.85	-0.60 degree Standard Deviation 1.14	-0.50 degree Standard Deviation 3.25

SECONDARY outcome

Timeframe: baseline and 24 weeks

substudy - Change in thrombus formation by Badimon chamber (low shear) from baseline to 24 weeks. Thrombus formation on a blood vessel measured by immunohistochemistry staining of tissue cross sections. μ(2)/mm is the area of thrombus. The low shear chamber (inner lumen diameter 0.2 mm, Reynolds number 30, shear rate 500 s- 1) simulates flow conditions of a normal coronary artery.

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Thrombus Formation (Low Shear) From Baseline to 24 Weeks	-1036 μ(2)/mm Standard Deviation 1364.39	-899.20 μ(2)/mm Standard Deviation 708.83	-203.75 μ(2)/mm Standard Deviation 1741.07

SECONDARY outcome

Timeframe: baseline and 24 weeks

substudy - Change in thrombus formation by Badimon chamber (high shear) from baseline to 24 weeks. Thrombus formation on a blood vessel measured by immunohistochemistry staining of tissue cross sections. The high shear chambers (inner lumen diameter 0.1 mm, Reynolds number 60, shear rate 1690 s- 1) mimic the rheologic conditions of a moderately stenosed coronary artery.

Outcome measures

Measure	Aspirin and Placebo n=8 Participants At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=5 Participants At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebo Only n=8 Participants At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Change in Thrombus Formation (High Shear) From Baseline to 24 Weeks	-3052.20 μ(2)/mm Standard Deviation 2859.52	-2798.80 μ(2)/mm Standard Deviation 3416.15	-753.00 μ(2)/mm Standard Deviation 1983.83

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: data not collected

substudy

Outcome measures

Outcome data not reported

Adverse Events

Aspirin and Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clopidogrel and Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebos Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aspirin and Placebo n=9 participants at risk At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Clopidogrel and Placebo n=10 participants at risk At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.	Placebos Only n=8 participants at risk At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
Infections and infestations Cholecystitis	0.00% 0/9	10.0% 1/10 • Number of events 1	0.00% 0/8

Other adverse events

Adverse event data not reported

Additional Information

Dr. Meagan O'Brien

Icahn School of Medicine at Mount Sinai

Email: Meagan.O'Brien@mssm.edu

Results disclosure agreements

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