A Randomised, Double-Blind, Outpatient, Crossover Study of the Anti-platelet Effects of AZD6140 Compared with Clopidogrel in Patients with Stable Coronary Artery Disease Previuosly Identified as Clopidogrel Non-responders or Responders [RESPOND] - RESPOND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

1, Provision of written informed consent
2, Documented stable CAD fulfilling any of the following, and taking ASA daily treament for at least 1 month prior to receiving their first dose of study medication: stable angina pectoris with objective evidence of CAD, previous myocardial infarction history, previous revascularisation history
3, Aged 18 years or older, male or female
4, Females of childbearing potential must: have a negative urine or blood pregancy test at enrolment, currently be using a hormonal contraceptive and agree to continue its use in addition to using barrier local contraception from screening through study completion. Women not using hormonal contraception must use double barrier local contraception

Genetic substudy
Provide written informed consent

Radioligand substudy
Provide written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who had ACS within 12 months of screening
2. Any of the following requiring antithrombotic treatment (eg, warfarin, clopidogrel,
ASA dose other than 75 mg to 100 mg daily) during the study period: atrial
fibrillation, mitral stenosis or prosthetic heart valve, coronary stent
3. Concomitant therapy with moderate or strong CYP3A inhibitors, CYP3A substrates
with narrow therapeutic index, or strong CYP3A inducers within 14 days of study
treatment. For example:
Moderate inhibitors: Amprenavir, aprepitant, diltiazem, erythromycin, fluconazole,
fosamprenavir, grapefruit juice, verapamil
Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin,
clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir.
Substrates with narrow therapeutic index: cyclosporine, quinidine.
Strong inducers: rifampin/rifampicin, phenytoin, carbamazepine.
The sponsor should be consulted for enrollment with any concomitant medicines
which are suspected of undergoing moderate/strong drug-drug interaction
4. Increased bleeding risk including:
Gastrointestinal (GI) bleeding within 30 days of dosing
Any history of intracranial, intraocular, retroperitoneal, or spinal bleeding
Major trauma within 30 days of dosing
Sustained uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg or
diastolic blood pressure [DBP] >100 mmHg)
History of hemorrhagic disorders that can increase the risk of bleeding,
eg, haemophilia, von Willebrand’s disease
Inability to discontinue required concomitant therapy with non-selective
non-steroidal anti-inflammatory drug (NSAID) at screening
Patients that have recently used within 30 days of dosing any oral or parenteral
antithrombotic agents, with the exception of clopidogrel and ASA.
Platelet count less than 100,000 mm3 or hemoglobin (Hb) <10 g/dL
5. Diabetic patients with glycated Hb (HbA1c)=10%
6. Contraindication or other reason that clopidogrel, ASA, or AZD6140 should not be
administered (eg, hypersensitivity, active bleeding, major surgery within 30 days of
dosing, any bleeding tendency [coagulation defects], acute or chronic liver disease
etc.)
7. History of drug addiction or alcohol abuse in the previous 2 years
8. Patient requires dialysis or has a creatinine clearance (CLCR) <30 mL/min as
calculated by the Cockcroft-Gault equation.
9. Participation in another investigational drug or device study within 30 days of
dosing
10. Current smokers using more than 1 pack per day (or equivalent) of any tobacco
containing products in the past 1 month
11. Recent (within 30 days of dosing) blood donation
12. Women who are pregnant or lactating
13. Patients that are scheduled for revascularization (eg, PCI, CABG) during the study
period
14. Any acute or chronic unstable condition in the past 30 days or other condition
which, in the opinion of the investigator, may either put the patient at risk or
influence the result of the study (eg, active cancer, risk for non-compliance, risk for
being lost to follow-up)
15. Patients with raised serum potassium (=5.5 mmol/L)
16. Involvement in the planning and conduct of the study (applies to AstraZeneca or
delegate staff, and study site staff)
17. Previous enrolment or randomisation of treatment in the present study
18. A suspected/manifested infection according to the World Health Organization
(WHO) risk categories 2, 3 and 4
19. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody,
or human immunodeficiency virus

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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