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Ticagrelore Alone Post PCI

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-80
SponsorShiraz University of Medical Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • aspirin 80 mg and clopidogrel 75 mg daily

    Drug

    post PCI patients received these two drugs as dual antiplatelet regimen

  • Ticagrelor 90 MG

    Drug

    Post PCI patients receive Ticagrelor 90 mg two times daily as single potent antiplatelet

Treatment groups

5,400 Participants
are divided into 2 treatment groups
Group A: Clopidogrel and aspirinActive comparator 1 intervention
Group B: ticagrelorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

stent thrombosis

Post PCI till 6 months any confirmed or suspected episodes of stent thrombosis based on ARCH definition

Time frame
6 months
2

Major adverse cardiovascular events

Any episodes of myocardial infarction, acute coronary syndrome, revascularization, hospital admission and major vascular events will be recorded

Time frame
6 months
3

Bleeding

any major or minor bleeding based on HASBLED criteria

Time frame
6 months

Secondary outcomes

1

Treatment related adverse reactions

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shiraz University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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