XIENCE DAPT 28
Research type
Research Study
Full title
XIENCE 28 Global Study
IRAS ID
243149
Contact name
Vijay Kunadian
Contact email
Sponsor organisation
Abbott Vascular
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Patients who come to the hospital for a stent implant procedure will be assessed for eligibility for inclusion in the clinical study by a member of the clinical trial team. This will be a physician and/or a research coordinator previously trained on the clinical trial protocol.
Once the study and what it entails has been thoroughly explained to the patient, if they choose to participate, they will be asked to sign an informed consent form to be included in the study. Once patients have provided consent to be part of the study, they will adhere to the requirements of the study protocol. All procedures required by the protocol are routine standard of care and participation carries no additional risk to the patient, so regardless of whether they choose to participate or not, they will be subject to the same risks.
The study is focused on patients who are at high risk of bleeding (HBR), and the primary objective is to evaluate the safety of 1 month (as short as 28 days) of dual antiplatelet therapy (DAPT), in patients who are implanted with a XIENCE stent. The type of product(s) being used in the study are known as drug eluting stents (DES). The main reason the sponsor is running this trial, is that there is limited clinical data looking at 1 month Dual Antiplatelet Therapy (DAPT) after drug eluting stent implantation in patients at high risk of bleeding.
Approximately 800 patients from approximately 50 hospitals or medical centres will be enroled into the study.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
18/WM/0141
Date of REC Opinion
30 May 2018
REC opinion
Unfavourable Opinion