VerifyNow® Aspirin Test and PRUTest Platelet Reactivity Compared to the AggRAM Aggregometer

The study will be performed in the clinical setting by trained professional operators.

Group 1: Platelet Activation Test 1, VerifyNow PRUTest and VerifyNow Aspirin Test Group 2:
Platelet Activation Test 2, AggRAM Aggregometer with and without the PGE1 reagent Ex-vivo
whole blood samples will be used from study patients who are currently receiving Dual
Anti-Platelet Therapy (DAPT) Clopidogrel and aspirin (ASA) or receiving either ASA or
Clopidogrel alone for a minimum of 4 weeks (on-drug) to test antiplatelet reactivity.

This study will enroll up to 170 including male and female patients aged 18 years or older
who have been on P2Y12 inhibitor (clopidogrel) and ASA Dual Antiplatelet Therapy for a
minimum of 4 weeks. Patients will be recruited over an approximate 2-month period from the
population of the study site(s). Because of the variability of biologic response to ASA and
P2Y12 inhibitor class of medications (and therefore platelet inhibition), patients may
contribute up to two samples for this study, provided that these samples are collected at
least 2 weeks apart.

After collection of 130 samples from on drug patients, there will be an interim enrollment
(only) pause and review to determine the number of DAPT non responders who were
non-responders to either Clopidogrel or ASA, and then to open enrollment to patients
prescribed Clopidogrel or ASA only in order to complete the missing ASA or Clopidogrel data
from negative assay results. No interim analysis of the data will be performed.

The workflow for the antiplatelet reactivity testing process will be consistent across all
sites. Expected duration of the study is dependent upon the site logistics but generally is
expected to last no more than two months.

Results generated during this study will be used solely for research purposes and will not be
used for antiplatelet management of study subjects. No patient follow up is required.

The study will include two VerifyNow System for PRUTest and Aspirin Test and AggRAM
Aggregometer, and trained professional operators.

All study data will be collected on Case Report Forms and all analysis will be performed by
Accriva.

Inclusion Criteria:

- Males and females 18 years or older

- Willing to participate and able to understand the study, including their rights and
any risks associated with their participation, and sign an informed consent

- Patients prescribed and regularly taking aspirin and clopidogrel (Plavix®) for a
minimum of 4 weeks prior to enrollment

- Able to donate a blood sample of up to 35 mL

Exclusion Criteria:

- Unable or unwilling to donate the required 35 mL blood sample

- Enrolled in any other study that involves an investigational drug and/or device

- Taking any NSAID

- Platelet count below 90,000/µL (LTA minimum), or above 741,000/µL

- Hematocrit level below 25%, or above 52%

- Patients should not be enrolled if taking any other substance that may specifically
block the P2Y12 receptor within the previous 14 days, or exposure to abciximab (within
14 days prior) and eptifibatide, or tirofiban (within the last 48 hours)

- Patients should not be enrolled if taking any of these medications (Average duration
times are listed for each drug):

- Ticlid (up to 5 days)

- Aggrenox (10 days)

- Pletal/Cilostazol (12 hours)

- Ibuprofen (Motrin, Advil) (8 hours)

- Naproxen (Aleve, Anaprox, Naprelan, Naprosyn) (24 hours)

- Diclofenac (Voltaren, Cataflam) (24 hours)

- Indocin (24 hours)

- Feldene (50 hours)

- tirofiban (Aggrastat®) within two days

- eptifibatide (Integrilin®) within two days

- abciximab (ReoPro®) within two weeks

- Vorapaxar for 30 days

- Received any therapy containing dipyridamole (Persantine®, Aggrenox®) within the
past 2 weeks