A Double-blind, Double-dummy, Parallel Group Randomised Dose Confirmation and Feasibility Study of AZD6140 + Acetyl Salicylic Acid (ASA) Compared with Clopidogrel + ASA in Patients with Non-ST Segment Elevation Acute Coronary Syndromes - DISPERSE2 - TIMI33 - DISPERSE 2 TIMI 33

Phase 1

Conditions: on-ST Segment Elevation Acute Coronary Syndromes
MedDRA version: 7.0 Level: LLT Classification code 10051592

Registration Number: EUCTR2004-000352-16-GB

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 990

Inclusion Criteria

1.Non-ST segment elevation ACS (index event) within the previous 48 hours documented by ischaemic symptoms of >10 minutes’ duration at rest, plus at least one of the following criteria described in either a or b:
a.Biochemical marker evidence of MI:
-Troponin T or I > local MI decision limit on at least one occasion during the first 24 hours after admission for the index clinical event.
-CK-MB, preferably CK-MB mass, >local MI decision limit on at least one occasion during the first 24 hours after admission for the index clinical event.
-In the absence of troponin or CK-MB, total CK >2x local MI decision limit during the first 24 hours after admission for the index clinical event.
b.ECG changes indicative of ischaemia:
-ST segment depression >0.5 mm (0.05 mV) in 2 or more contiguous leads.
-Transient ST segment elevation <20 mins, >1 mm (0.1 mV) in 2 or more contiguous leads.
-T-wave abnormalities - inversion >1 mm (0.1 mV) in 2 or more contiguous leads.
2.Provision of written informed consent.
3.Females and males aged 18 years and over.

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.Persistent ST segment elevation >20 minutes.
2.More than 48 hours from onset of symptoms of non-ST segment elevation ACS to expected initiation of therapy (first dose).
3.PCI within the 48 hours prior to the index event or PCI within the 48 hours prior to randomisation.
4.Coronary angiography in the 48 hours prior to randomisation showing no significant narrowing of the coronary arteries or <50% diameter stenosis.
5.Any of the following conditions associated with increased risk of bleeding:
a.History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding.
b.Gastrointestinal bleeding within the 6 months prior to randomisation.
c.Gastric or duodenal ulcer disease verified by endoscopy or barium meal contrast technique within the 6 months prior to randomisation.
d.Persistent uncontrolled hypertension: systolic >180 mmHg or diastolic >100 mmHg with or without anti-hypertensive treatment (as demonstrated by repeated BP measurements >180/100 mmHg including the final BP measurement before randomisation).
e.Haemorrhagic disorder.
f.Major surgical procedure or trauma within the 30 days prior to randomisation.
g.Intracranial aneurysm or vascular malformation.
6.Chronic oral anticoagulation required eg, atrial fibrillation, mitral stenosis, rheumatic valve disease, prosthetic heart valves; or concomitant oral anticoagulation therapy within the 7 days prior to randomisation.
7.Chronic daily dosing with non-selective NSAIDs required eg, rheumatoid arthritis.
8.Thrombolytic therapy administered for STEMI or any other condition in the 7 days prior to randomisation.
9.Contraindications for ASA treatment, including allergy or intolerance that would prevent its use during the study.
10.Concomitant therapy with digoxin or strong cytochrome P450 3A4 inhibitors or cytochrome P450 3A4 substrates with a narrow therapeutic index.
11.Known lactose intolerance.
12.Serum creatinine level >3.0 mg/dL (265 mmol/L).
13.Known active liver disease or Visit 1 elevated liver function tests of ALT >2x ULN or total bilirubin >1.5x ULN (local laboratory reference ranges).
14.Haemoglobin (Hb) level <100 g/L (6.2 mmol/L).
15.Platelet count <100x109/L.
16.CABG within the 3 months prior to randomisation.
17.Non-haemorrhagic stroke within the 30 days prior to randomisation.
18.Active cancer (excluding skin basal cell carcinoma).
19.Female of childbearing potential (female patients must be either post-menopausal for 1 year, or surgically sterile).
20.Patients with disease or disorders which in the opinion of the investigator, may either put the patient at risk because of participation in the study or inappropriately influence the result of the study, or the patient’s ability to participate in the study.
21.Inability to complete the study according to the protocol, eg, inability to complete questionnaires in local language.
22.Participation in another investigational drug study within one month prior to randomisation or previous randomisation in this study.

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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