Other Clinical Trial - BIOFLOW-Dual Anti-Platelet Therapy

Clinical Trial Summary

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomised controlled clinical study. A total of 1,948 subjects will be randomised 1:1 to receive either Orsiro or Resolute onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05549440
Study type	Interventional
Source	Chinese University of Hong Kong
Contact	Daniel Xu
Phone	35051518
Email	danielxu@cuhk.edu.hk
Status	Recruiting
Phase	N/A
Start date	June 4, 2020
Completion date	September 2024

BIOFLOW-Dual Anti-Platelet Therapy — BIOFLOW-DAPT

Clinical Trial Summary

Clinical Trial Description

Study Design