Recruiting PHASE4 Coronary Artery Disease

Compares treatment options for Coronary Artery Disease

Official title IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome

ClinicalTrials.gov ID: NCT06451198

What this study is testing

What is Indobufen?

Indobufen is an investigational medicine, 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
The OPTION2 trial (randomized controlled trial of IndObufen versus asPirin after coronary drug-eluting stent implantaTION in elderly patients with acute coronary syndrome) was designed to compare the 1-year clinical efficacy and safety of indobufen-based dual antiplatelet therapy (DAPT) (indobufen 100mg bid plus ticagrelor 90mg bid) or conventional DAPT (aspirin 100mg qd plus ticagrelor 90mg bid) in acute coronary syndrome (ACS) patients aged over 65 years old undergoing coronary drug-eluting stent (DES) implantation.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 65 and older

You may be able to join if

  • Age over 65 years old
  • Diagnosed with acute coronary syndrome (unstable angina/ non-ST elevation myocardial infarction/ ST elevation myocardial infarction)
  • Treated with at least 1 DES implanted in the coronary lesion
  • Receiving dual antiplatelet therapy (aspirin plus ticagrelor)
  • Agree to attend the trial

You likely can't join if

  • Elective surgical procedure planned within 12 months
  • Life expectancy ≤1 year
  • Known allergy or intolerance to aspirin, ticagrelor or nonsteroidal anti-inflammatory drugs (NSAIDs)
  • History of cerebral hemorrhage
  • History of stroke in six months
  • Active bleeding
See the full eligibility criteria
Who can join
  • Age over 65 years old
  • Diagnosed with acute coronary syndrome (unstable angina/ non-ST elevation myocardial infarction/ ST elevation myocardial infarction)
  • Treated with at least 1 DES implanted in the coronary lesion
  • Receiving dual antiplatelet therapy (aspirin plus ticagrelor)
  • Agree to attend the trial
What rules you out
  • Elective surgical procedure planned within 12 months
  • Life expectancy ≤1 year
  • Known allergy or intolerance to aspirin, ticagrelor or nonsteroidal anti-inflammatory drugs (NSAIDs)
  • History of cerebral hemorrhage
  • History of stroke in six months
  • Active bleeding
  • Known relevant hematological deviations
  • Known, clinically important thrombocytopenia (i.e., \<100\ 10\^9/L) or anemia (i.e., \<90g/L)
  • Active cancer
  • Concomitant use of oral anticoagulants
  • Active participation in another clinical study
  • Other situations in which the investigator considers unsuitable to attend the study

The study team makes the final eligibility decision.

Where it's taking place

  • Shanghai, Shanghai Municipality, China

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, 65 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Shanghai, Shanghai Municipality, China. 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.