Protocol summary
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Study aim
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To investigate the clinical benefits and disadvantages of Ticagrelor monotherapy after revascularization (PCI) in chronic coronary syndrome patients.
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Design
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This study is a randomized, two-arm, open-label, non-inferiority trial with 1:1 allocation between Ticagrelor monotherapy and conventional DAPT treatment group.
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Settings and conduct
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This study is a single-center, two-arm, open-label, non-inferiority clinical trial which will be conducted in Professor Kojuri heart clinic, Shiraz, south Iran to evaluate the safety and efficacy of ticagrelor monotherapy in comparison to conventional DAPT regimen in CCS patients after PCI.
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Participants/Inclusion and exclusion criteria
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Chronic coronary syndrome patients aged over 20 years without contraindications for receiving ticagrelor and recent events related to increased risk of bleeding
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Intervention groups
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Ticagrelor monotherapy
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Main outcome variables
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stent thrombosis
bleeding
General information
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Reason for update
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The blinding part of the study was modified and the changes in the desired part were modified.
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Acronym
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TICALONE-TAHA10
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IRCT registration information
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IRCT registration number:
IRCT20240701062299N1
Registration date:
2024-07-05, 1403/04/15
Registration timing:
prospective
Last update:
2024-08-03, 1403/05/13
Update count:
3
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Registration date
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2024-07-05, 1403/04/15
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-07-10, 1403/04/20
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Expected recruitment end date
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2026-08-11, 1405/05/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Efficacy and Safety of Ticagrelor Monotherapy Compared to Dual Antiplatelet Therapy in Patients With Chronic Coronary Syndrome After Percutaneous Coronary Intervention
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Public title
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Ticagrelor Monotherapy vs. DAPT in CCS patients post-PCI
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male or female above 20 years of age undergoing PCI with a drug-eluting stent for treating chronic coronary syndrome.
The patient has provided written informed consent as approved by the ethics committee.
Exclusion criteria:
Contraindication to aspirin, clopidogrel, ticagrelor, or any other reason that study drug should not be administered (including hypersensitivity, moderate or severe liver disease, active bleeding, and major surgery within 30 days)
Atrial fibrillation or other indication for oral anticoagulant therapy.
Concomitant oral or IV therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices (cyclosporine, and quinidine), or strong CYP3A inducers (rifampin, rifampicin, phenytoin, and carbamazepine)
Females of child-bearing age unless negative pregnancy test at screening and willing to use effective contraception for the duration of trial
Females who are breastfeeding at the time of enrolment.
Previous PCI in the last 6 months.
Current (same hospitalization) or previous (within 12 months) acute coronary syndrome.
History of definite stent thrombosis.
Concomitant cardiac valve disease requiring invasive therapy.
Patients with acute heart failure, active myocarditis, or cardiomyopathy.
Patient in hemodialysis.
History of stroke or transient ischemic cerebrovascular accident.
History of intracranial hemorrhage or other intracranial pathology associated with increased bleeding risk.
Hemoglobin <10 g/dL
Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy.
Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor.
Participation in another trial with an investigational drug or device.
Assessment that the subject is not likely to comply with the study procedures or have complete follow-up.
Known drug or alcohol dependence within the past 12 months as judged by the investigator.
Patients with planned surgical intervention to treat any cardiac or non-cardiac condition.
Unsuccessful PCI or PCI without optimal stent placement; this decision is made by the supervising interventional cardiologist.
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Age
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From 20 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
5400
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be randomly allocated to either the control group or the experimental group in a 1:1 ratio using permuted block randomization through a web-based randomization service (https://www.sealedenvelope.com/randomisation/simulation/). A block size of four will be utilized to ensure balance between the groups.
Allocation concealment will be ensured as the randomization service will not be accessed by the interventional cardiologist until the patient has been recruited into the trial. Recruitment occurs after diagnostic angiography and before stent insertion.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, the primary physician (care provider) is not blinded to the allocation of the patient to the intervention or control group. On the other hand, participants, researchers, health care and clinical trial personnel, including those in charge of data collection, analysts, statistical analyzers, and article authors, are kept blind to the assignment to the study groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-06-01, 1403/03/12
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Ethics committee reference number
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IR.SUMS.MED.REC.1403.150
Health conditions studied
1
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Description of health condition studied
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chronic coronary syndrome
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ICD-10 code
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I25
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ICD-10 code description
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Chronic ischemic heart disease
Primary outcomes
1
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Description
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stent thrombosis
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Timepoint
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1, 3, 6, and 12 months post PCI
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Method of measurement
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History and physical examinations indicating the need for revascularization.
2
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Description
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Bleeding (BARC type 3 to 5)
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Timepoint
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1, 3, 6, and 12 months post PCI
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Method of measurement
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History and physical exam
Secondary outcomes
1
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Description
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Major Adverse Cardiovascular Event (MACE)
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Timepoint
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1, 3, 6, and 12 months post PCI
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Method of measurement
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Interview
2
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Description
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All-cause death
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Timepoint
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1, 3, 6, and 12 months post PCI
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Method of measurement
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Interview
Intervention groups
1
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Description
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Intervention group: Ticagrelor monotherapy after PCI
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Category
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Treatment - Drugs
2
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Description
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Control group: conventional dual anti-platelet therapy
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Due to confidentiality of patients' information
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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study protocol and study results article
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When the data will become available and for how long
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One month after publishing the final results if there is a suitable request and the discretion of the responsible authorities
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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It will be possible to use the data and documents only if the analysis protocol is presented and approved by the people responsible for the plan.
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From where data/document is obtainable
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It is possible to take action to receive the study documents or data only by communicating with the scientific responsible person of the project (whose specifications were presented in the relevant section).
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What processes are involved for a request to access data/document
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E-mail to the person in charge of science and presenting the analysis protocol and then review and approval by the study authorities
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Comments
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