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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02214654
Recruitment Status : Unknown
Verified April 2014 by Xiaofei Wang, Tianjin First Central Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Information provided by (Responsible Party):
Xiaofei Wang, Tianjin First Central Hospital

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.

Condition or disease
Type 2 Diabetes Mellitus; Stable Coronary Disease

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 characteristics of the study and confirm their agreement to participate by signing the informed consent document.

iii- Assist with patient assessment, record the information in the case report form. Based on the data we get from the case report form, assign the patient to the experimental or control group by stratified randomization.

ⅳ- At visit 2 to obtain blood sample from peripheral vessel and analyze the density of CECs,sCD40L and hs-CRP by flow cytometry (FCM), ELISA and particle-enhanced turbidimetric immunoassay.

ⅴ- All patients are given aspirin 100mg/qd orally and the experimental group given ticagrelor 90mg/bid while the control group clopidogrel 75mg/qd for 30 days.

ⅵ- At visit 3 repeating step ⅳ and making comparison on numbers of CECs and CD40L between the two groups, and finish a statistic analysis.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 144 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: A Pilot Study To Examine The Effects Of Ticagrelor To Protect Against Type 2 Diabetes-Induced Vascular Damage
Study Start Date : August 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor
U.S. FDA Resources

ticagrelor,clopidogrel,antiplatelet drugs

Primary Outcome Measures :
  1. circulation endothelial cell [ Time Frame: 1 month ]

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients will be enrolled from outpatient and in hospital in Tianjin First Central Hospital

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures.
  2. 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)
  3. 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
  4. No medication history of clopidogrel/ticagrelor for at least 1 months
  5. Female or male, and any race, aged≥18 years, not pregnant.

Exclusion Criteria:

  1. Blood pressure>160/100 mm Hg;
  2. Hypercholesterolemia(LDL-c >240mg/dl);
  3. Hemoglobin A1c ≥ 10%;
  4. Platelet count less than 10*10^9/L or hemoglobin <10 g/dL;
  5. Intolerance or allergy to clopidogrel/ticagrelor or any of the excipients;
  6. Patient with known inflammatory conditions or those on anti-inflammatory drug therapy;
  7. Second and third degree atrioventricular block;
  8. chronic obstructive lung disease or asthma;
  9. Creatinine>2 mg/dl;
  10. Malignancy;
  11. Moderate or severe hepatic impairment;
  12. History of intracranial haemorrhage;
  13. Active pathological bleeding;
  14. Pregnancy or lactation;
  15. Any condition that increases the risk for noncompliance or being lost to follow-up;
  16. Medicine history of potent CYP3A4 inhibitor(ketoconazole, clarithromycin,etc.);
  17. No provision of informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02214654

China, Tianjin
Tianjin First Central Hospital Not yet recruiting
Tianjin, Tianjin, China, 300192
Tianjin First Central Hospital Not yet recruiting
Tianjin, China, 300192
Contact: Xiaofei Wang, doctor   
Sponsors and Collaborators
Tianjin Medical University
Principal Investigator: Xiaofei Wang, doctor Tianjin First Central Hospital

Responsible Party: Xiaofei Wang, Tianjin International Medical Center, Tianjin First Central Hospital Identifier: NCT02214654     History of Changes
Other Study ID Numbers: ISSBRIL0241
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Coronary Disease
Coronary Artery Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs