Comparison of TIcagrelor and Clopidogrel in Patients With Coronary Artery diseaSe and Type 2 Diabetes Mellitus (TICS-DM)
TICS-DM
1 other identifier
interventional
30
1 country
3
Brief Summary
Patients with type 2 diabetes mellitus (T2DM), have a high prevalence of suboptimal response to clopidogrel (up to 40%). This impaired response to antiplatelet drugs has been consistently associated with a higher risk of adverse ischemic outcomes. Different strategies have been suggested to overcome variability in response to clopidogrel and improve clinical outcomes in diabetic patients. One of these strategies is the use of newer P2Y12 inhibitors, such as ticagrelor, with more potent and consistent platelet inhibitory effects compared to clopidogrel. In summary, since patients with T2DM continue to have enhanced platelet reactivity despite the administration of commonly used dual antiplatelet therapy with aspirin and standard doses of clopidogrel, newer and more potent antiplatelet treatment strategies are warranted in this high-risk population. The purpose of the present study is to compare platelet inhibitory effects achieved with ticagrelor versus clopidogrel, both on top of aspirin therapy, in patients with type 2 DM and stable coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 coronary-artery-disease
Started Apr 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 14, 2016
April 1, 2016
1.7 years
May 27, 2015
April 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Platelet reactivity
maximal platelet aggregation, measured with light transmittance aggregometry (using 20 μM ADP as agonist), achieved after 1 week of treatment with ticagrelor or clopidogrel
7 days
Study Arms (2)
Group A
EXPERIMENTALAfter providing written informed consent, eligible subjects will be randomized in a 1:1 fashion to group A or B. Ticagrelor (180-mg loading dose the first day followed by 90-mg b.i.d. maintenance dose) for one week; washout period of 2-4 weeks; crossover to clopidogrel (600-mg loading dose the first day followed by 75-mg daily maintenance dose) for one-week.
Group B
EXPERIMENTALAfter providing written informed consent, eligible subjects will be randomized in a 1:1 fashion to group A or B. Clopidogrel (600-mg loading dose the first day followed by 75-mg daily maintenance dose) for one-week; washout period of 2-4 weeks; crossover to ticagrelor (180-mg loading dose the first day followed by 90-mg b.i.d. maintenance dose) for one week.
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures
- Age between 18 and 75 years
- Type 2 DM according to ADA criteria
- Angiographically documented CAD
- Chronic treatment (\>1 month) with aspirin (100mg/day)
You may not qualify if:
- Known allergies to aspirin, clopidogrel, or ticagrelor
- Blood dyscrasia
- Any recent acute coronary syndrome (\<30 days) or hemodinamic instability
- Recent antiplatelet therapy (\<14 days), with the exception of ASA, including: thienopyridines, cilostazol, dipiridamol, glycoprotein IIb/IIIa inhibitors
- Oral anticoagulation with a coumarin derivative
- Concomitant treatment with a potent CYP3A4 inhibitor (e.g. ketoconazole, claritromicine, nefazodone, ritonavir, atazanavir)
- Any active bleeding
- Platelet count \<100x106/microl
- Severe chronic kidney disease (creatinine clearance measured with Cockcroft-Gault formula \<30ml/min)
- Any active neoplasm
- Baseline ALT \>2.5 times the upper limit of normality
- Pregnant or childbearing females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spanish Society of Cardiologylead
- AstraZenecacollaborator
Study Sites (3)
Hospital Universitari de Bellvitge - IDIBELL
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120, Spain
Related Publications (1)
Marcano AL, Gracida M, Roura G, Gomez-Lara J, Romaguera R, Teruel L, Fuentes L, Muntane-Carol G, Merono O, Sosa SG, Gomez-Hospital JA, Comin-Colet J, Ferreiro JL. Antiplatelet efficacy of ticagrelor versus clopidogrel in Mediterranean patients with diabetes mellitus and chronic coronary syndromes: A crossover pharmacodynamic investigation. Front Cardiovasc Med. 2022 Nov 22;9:1057331. doi: 10.3389/fcvm.2022.1057331. eCollection 2022.
PMID: 36483622DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Luis Ferreiro
Hospital Universitari de Bellvitge - IDIBELL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 27, 2015
First Posted
May 29, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
April 14, 2016
Record last verified: 2016-04