Status:
UNKNOWN
A Pilot Study To Examine The Effects Of Ticagrelor To Protect Against Type 2 Diabetes-Induced Vascular Damage
Lead Sponsor:
Tianjin Medical University
Collaborating Sponsors:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus；
Stable Coronary Disease
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to compare clopidogrel with ticagrelor which one has stronger anti-inflammation effect to protect against type 2 diabetes-induced vascular damage.
Detailed Description
i- Verify the study inclusion and exclusion criteria at visit 1. ii- Inform patients (verbally and in writing) and their caregivers (when considered necessary and with the patient's consent) of the c...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures.
- A previous or new diagnosis of type 2 diabetes mellitus, document by one of following criteria:1）Hemoglobin A1c of ≥6.5% at diagnosis;2) Fasting plasma glucose (FPG) ≥126mg/dL (7.0 mmol/L);3) Two-hour plasma glucose≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);4) with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose≥200mg/dL (11.1 mmol/L)( confirmed by repeat testing)
- A previous or new diagnosis of stable CAD according to ICD 10 for at least 6 months, document by following criteria: 1) Stable angina; 2) No AMI or NSTE-ACS within 1 month;and(or) 3) EKG with ischemic ST-segment and(or) T-wave change; and(or)4) coronory artery stenosis ≥50% viewed by coronary CTA or coronary angiography
- No medication history of clopidogrel/ticagrelor for at least 1 months
- Female or male, and any race, aged≥18 years, not pregnant.
Exclusion
- Blood pressure\>160/100 mm Hg;
- Hypercholesterolemia(LDL-c \>240mg/dl);
- Hemoglobin A1c ≥ 10%;
- Platelet count less than 10\*10\^9/L or hemoglobin \<10 g/dL;
- Intolerance or allergy to clopidogrel/ticagrelor or any of the excipients;
- Patient with known inflammatory conditions or those on anti-inflammatory drug therapy;
- Second and third degree atrioventricular block;
- chronic obstructive lung disease or asthma;
- Creatinine\>2 mg/dl;
- Malignancy;
- Moderate or severe hepatic impairment;
- History of intracranial haemorrhage;
- Active pathological bleeding;
- Pregnancy or lactation;
- Any condition that increases the risk for noncompliance or being lost to follow-up;
- Medicine history of potent CYP3A4 inhibitor(ketoconazole, clarithromycin,etc.);
- No provision of informed consent.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT02214654
Start Date
August 1 2014
End Date
June 1 2015
Last Update
August 12 2014
Active Locations (2)
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1
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China, 300192
2
Tianjin First Central Hospital
Tianjin, China, 300192