NCT02214654

Unknown

A Pilot Study To Examine The Effects Of Ticagrelor To Protec...

Tianjin Medical University Source

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Other study identifiers

Sponsor study identifier

ISSBRIL0241

Study Type

observational

Estimated enrollment

144

Locations

1 country

Sites

2

Timeline

Study Start

August 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2015

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2015

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 144 participants
Study completion date: June 2015
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2014
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 10, 2014
Actual (reported)
First Posted
August 12, 2014
Actual (reported)
Primary Completion
March 2015
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2015
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: August 12, 2014
Status Verified: April 2014
Last Update Submitted: August 11, 2014

Conditions

Stable Coronary Disease Type 2 Diabetes Mellitus；

Outcome Measures

Primary Outcomes (1)

circulation endothelial cell
1 month

Study Arms (1)

ticagrelor，clopidogrel，antiplatelet drugs

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

Sponsors & Collaborators

AstraZeneca
Industrycollaborator
Tianjin Medical University
Otherlead

Study Sites (2)

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300192, China

Tianjin First Central Hospital

Tianjin, 300192, China

Xiaofei Wang, doctorCONTACTwangxiaofei@medmail.com.cn

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 MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2015

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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;
+2 more criteria

Contact the study team to confirm eligibility.

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2015

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

August 12, 2014

Record last verified: 2014-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02214654
Data provider: ClinicalTrials.gov
Source updated: 2014-08-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:35 UTC

Locations

CN(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

ticagrelor，clopidogrel，antiplatelet drugs

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations