A Pilot Study To Examine The Effects Of Ticagrelor To Protect Against Type 2 Diabetes-Induced Vascular Damage

NCT02214654 | Unknown DMC

• 1 other identifier: ISSBRIL0241
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus；; Stable Coronary Disease

Outcome Measures

Primary Outcomes (1)

• circulation endothelial cell

  1 month

Study Arms (1)

ticagrelor，clopidogrel，antiplatelet drugs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients will be enrolled from outpatient and in hospital in Tianjin First Central Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tianjin Medical University: lead
• AstraZeneca: collaborator

Study Sites (2)

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300192, China

Location

Tianjin First Central Hospital

Tianjin, 300192, China

Location

Biospecimen

Retention: NONE RETAINED

We will collect blood samples from the vena mediana cubiti, volume of sample blood will be 5ml.Centrifuge samples at 700gfor 20 min at 4 °C with no brake.Remove gently the upper phase (plasma) with a 5 ml pipette into a separate tube and store in 0.25 ml aliquots.Distribute 500 μl of samples into one isotype control and three sample tubes and add the special antibodies.Then account the CECs and sCD40/40L,etc.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xiaofei Wang, doctor

  Tianjin First Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tianjin International Medical Center

Study Record Dates

• First Submitted: August 10, 2014
• First Posted: August 12, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 12, 2014

Record last verified: 2014-04

Locations

CN (2)