Assessment of Coagulation and Thrombocyte Function After Termination of Ticagrelor

NCT02297971 | Completed DMC

• 1 other identifier: 2013/001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of bleeding when it is continued peri-operatively have to be weighed against the risk of coronary artery thrombosis when stopped. This study aims to assess coagulation and thrombocyte function every other day in patients who are taking ticagrelor after coronary artery stents and discontinue therapy at the end of one year.

Conditions

PCI; Coronary Stents

Outcome Measures

Primary Outcomes (1)

• Platelet aggregometry

  Platelet aggregometry using Multiplate assay would be done prior to termination of ticagrelor treatment and thereafter every other day of 10 days.

  0 - 10 days

Secondary Outcomes (2)

• Thromboelstography

  0-10 days

• Coagulation function tests

  0-10 days

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have previously had a coronary artery syndrome treated by PCI and stent placement and who are taking the oral anti platelet drugs aspirin and ticagrelor would be included into the study.

You may qualify if:

• \- Patients who are on the Cardiology Clinic's database at the University Hospital, Örebro and shall terminate ticagrelor after one year following PCI and stent placement would be identified and offered to take part in this study.

You may not qualify if:

• \- Non-responders (not partial responders) to ticagrelor would be excluded from the study. Additionally, patients who are either taking NSAID's regularly or during the last 2 weeks prior to study start would also be excluded as those who have language or cognitive limitations.

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

University Hospital

Örebro, 701 85, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for analysis of complement, coagulation factors and other biochemical markers

Study Officials

• Anil Gupta, MD, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 21, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

SE (1)