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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Tianjin Medical University
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Xiaofei Wang, Tianjin First Central Hospital
ClinicalTrials.gov Identifier:
NCT02214654
First received: August 10, 2014
Last updated: August 11, 2014
Last verified: April 2014
  Purpose

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
Type 2 Diabetes Mellitus;
Stable Coronary Disease

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University:

Primary Outcome Measures:
  • circulation endothelial cell [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 144
Study Start Date: August 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
ticagrelor,clopidogrel,antiplatelet drugs

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02214654

Locations
China, Tianjin
Tianjin First Central Hospital Not yet recruiting
Tianjin, Tianjin, China, 300192
China
Tianjin First Central Hospital Not yet recruiting
Tianjin, China, 300192
Contact: Xiaofei Wang, doctor       wangxiaofei@medmail.com.cn   
Sponsors and Collaborators
Tianjin Medical University
AstraZeneca
Investigators
Principal Investigator: Xiaofei Wang, doctor Tianjin First Central Hospital
  More Information

No publications provided

Responsible Party: Xiaofei Wang, Tianjin International Medical Center, Tianjin First Central Hospital
ClinicalTrials.gov Identifier: NCT02214654     History of Changes
Other Study ID Numbers: ISSBRIL0241
Study First Received: August 10, 2014
Last Updated: August 11, 2014
Health Authority: China:Chinese food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014