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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Xiaofei Wang, Tianjin First Central Hospital

Tracking Information
First Submitted Date August 10, 2014
First Posted Date August 12, 2014
Last Update Posted Date August 12, 2014
Study Start Date August 2014
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 2014)
circulation endothelial cell [ Time Frame: 1 month ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Pilot Study To Examine The Effects Of Ticagrelor To Protect Against Type 2 Diabetes-Induced Vascular Damage
Official Title A Pilot Study To Examine The Effects Of Ticagrelor To Protect Against Type 2 Diabetes-Induced Vascular Damage
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 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]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Retention:   None Retained
Description:
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.
Sampling Method Probability Sample
Study Population All patients will be enrolled from outpatient and in hospital in Tianjin First Central Hospital
Condition
  • Type 2 Diabetes Mellitus;
  • Stable Coronary Disease
Intervention Not Provided
Study Groups/Cohorts ticagrelor,clopidogrel,antiplatelet drugs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 11, 2014)
144
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2015
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02214654
Other Study ID Numbers ISSBRIL0241
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Xiaofei Wang, Tianjin First Central Hospital
Study Sponsor Tianjin Medical University
Collaborators AstraZeneca
Investigators
Principal Investigator: Xiaofei Wang, doctor Tianjin First Central Hospital
PRS Account Tianjin Medical University
Verification Date April 2014