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New treatment option for Coronary Artery Disease
Official title Ticagrelore Alone Post PCI
ClinicalTrials.gov ID: NCT06509893
What this study is testing
What is aspirin 80 mg and clopidogrel 75 mg daily?
aspirin 80 mg and clopidogrel 75 mg daily is an investigational medicine, given as an once-daily, being studied as a potential treatment for coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- After PCI for CCS patients, single center double blind randomization will be done and patients will receive aspirin 80 mg and clopidogrel 75 mg versus 90 mg two times daily of ticagrelor, for 6 months and MACE will be followed in registry of professor Kojuri cardiology clinic
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80
You may be able to join if
- Male or female above 20 years of age undergoing PCI with a drug-eluting stent for chronic coronary syndrome
- The patient has provided written informed consent as approved by the ethics committee of the Shiraz University of Medical Sciences.
You likely can't join if
- Contraindication to aspirin, clopidogrel, ticagrelor, or any other reason that study drug should not be administered (including hypersensitivity...
- 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...
- 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.
- Unsuccessful PCI or PCI without optimal stent placement; this decision is made by the supervising treatment cardiologist.
See the full eligibility criteria
- Male or female above 20 years of age undergoing PCI with a drug-eluting stent for chronic coronary syndrome
- The patient has provided written informed consent as approved by the ethics committee of the Shiraz University of Medical Sciences.
- 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...
- 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.
- Unsuccessful PCI or PCI without optimal stent placement; this decision is made by the supervising treatment cardiologist.
- patients with anatomical SYNTAX score ≥23 prior to PCI
- Patients with planned surgical intervention to treat any cardiac or non-cardiac condition.
- 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.
- Acute heart failure.
- Active myocarditis.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shiraz, Fars, Iran
- Shiraz, Iran
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shiraz, Fars, Iran; Shiraz, Iran. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.