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Anticoagulant

Heparin Dosing for Percutaneous Coronary Intervention (HD-PCI Trial)

N/A
Recruiting
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing elective PCI
- Patients undergoing elective PCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after pci
Awards & highlights

HD-PCI Trial Summary

This trial is testing whether higher or lower doses of heparin are better for people undergoing a specific kind of heart procedure.

Who is the study for?
This trial is for adults who need an elective procedure to open blocked arteries in the heart (PCI). Hospitals must submit data to a registry and follow the heparin dose policy. It's not for those under 18, planning a specific complex PCI, or non-residents who can't be followed up locally.Check my eligibility
What is being tested?
The HD PCI trial compares two dosing strategies of heparin: a higher dose versus a lower dose during heart artery-opening procedures. Patients are randomly assigned to either group across different hospitals that switch policies periodically.See study design
What are the potential side effects?
Heparin can cause bleeding, bruising at injection sites, allergic reactions, and in rare cases may lead to an unusual clotting disorder called HITT (heparin-induced thrombocytopenia and thrombosis).

HD-PCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a planned procedure to open blocked arteries in my heart.
Select...
I am scheduled for a planned procedure to open blocked arteries in my heart.

HD-PCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after pci
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after pci for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization
Secondary outcome measures
Number of Participants with any of the following: death, myocardial infarction, target vessel revascularization or major bleeding
Number of Participants with major bleeding
Other outcome measures
Number of Participants with definite stent thrombosis
Number of Participants with either of the following: death or myocardial infarction

HD-PCI Trial Design

2Treatment groups
Active Control
Group I: Higher Dose Unfractionated Heparin Treatment PeriodActive Control1 Intervention
A centre wide policy of administering 100 U/kg bolus of intravenous unfractionated heparin (UFH) for elective percutaneous coronary intervention (PCI) procedures will be implemented during the Higher Dose UFH treatment period.
Group II: Lower Dose Unfractionated Heparin Treatment PeriodActive Control1 Intervention
A centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures will be implemented during the Lower Dose UFH treatment period.

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
663,912 Total Patients Enrolled
Sanjit Jolly, MDStudy ChairPopulation Health Research Institute

Media Library

Higher Dose UFH (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04049591 — N/A
Cardiovascular Disease Research Study Groups: Higher Dose Unfractionated Heparin Treatment Period, Lower Dose Unfractionated Heparin Treatment Period
Cardiovascular Disease Clinical Trial 2023: Higher Dose UFH Highlights & Side Effects. Trial Name: NCT04049591 — N/A
Higher Dose UFH (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04049591 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being observed in this research endeavor?

"Affirmative. Clinicaltrials.gov data indicates that this medical investigation, which was initially made public on March 2nd 2022, is currently in search of participants. 16000 people must be recruited from a single location to fulfill the requirements of the trial."

Answered by AI

What conditions or ailments is Higher Dose Unfractionated Heparin Treatment Period typically administered to?

"High-Dose Unfractionated Heparin is a frequently prescribed medication for treating medical devices. Additionally, it can be employed to mitigate the effects of sprains, unstable angina pectoris, and atrial fibrillation."

Answered by AI

Is this study unprecedented in terms of its scope and methodology?

"Currently, there are 36 distinct clinical trials examining the effectiveness of Higher Dose Unfractionated Heparin Treatment Period in 197 cities and 21 nations. The initial study commenced in 2006, with Ash Access Technology as its primary sponsor; 415 individuals were enrolled into this Phase 3 drug approval trial which ultimately concluded successfully. Since then, an additional 189 experiments have been executed."

Answered by AI

Are there other investigations that have explored the potential of Higher Dose Unfractionated Heparin Treatment Period?

"There are presently 36 studies in progress for Higher Dose Unfractionated Heparin Treatment Period, of which 12 have reached Phase 3. Sherbrooke, Quebec is the primary site hosting these trials; nevertheless, 367 other locations across Canada and abroad also offer this treatment."

Answered by AI

Are there any enrollments still possible for this experiment?

"Affirmative, the information published on clinicaltrials.gov suggests that this medical trial is actively recruiting patients. The study was first listed on March 2nd, 2022 and last modified on September 19th of the same year. Specifically, 16000 volunteers need to be accepted at a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Higher vs. Lower Dose Heparin for PCI
2022. "Higher vs. Lower Dose Heparin for PCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04049591.
~2667 spots leftby Oct 2024
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