Optimizing Aspirin and Clopidogrel Therapy (BOchum CLopidogrel and Aspirin Plan)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dual antiplatelet therapy with acetylsalicylic acid (ASA, aspirin) and clopidogrel is of great importance for treatment following coronary stenting. Unfortunately the variable platelet inhibitory effectiveness compromises the antithrombotic benefit of dual antiplatelet therapy. The aim of this prospective single centre study was to reduce the low response incidence of dual antiplatelet therapy with ASA and clopidogrel based on a standardized therapy algorithm.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

NCT03587324

Vascular Surgery Patient With PAD / Carotid Stenosis

COMPLETED NA

Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention

NCT00611286

Coronary Artery Disease

COMPLETED PHASE4

Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation

NCT00822536

Coronary Artery Disease Stent Thrombosis Myocardial Ischemia

COMPLETED PHASE4

The Effect of Clopidogrel and Ticagrelor With and Without Acetylsalicylic Acid (ASA) on Hemostatic System Activation at the Site of Plug Formation in Vivo in Man

NCT02120092

Acute Coronary Syndrome

COMPLETED PHASE2

ASA- and Clopidogrel-Responsiveness in Patients With Peripheral Arterial Occlusive Disease and Interventional Procedures

NCT00593762

Peripheral Arterial Occlusive Disease

SUSPENDED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Platelet function testing using whole blood aggregometry was performed 48 hours following coronary stenting (either acute coronary syndromes or stable coronary artery disease). The antiplatelet therapy included a loading dose of 600 mg clopidogrel and 500 mg ASA, followed by 75 mg clopidogrel and 100 mg ASA once daily. Clopidogrel low-response (CLR) and/or ASA (ASA low response) were treated according to a structured therapy plan.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

aspirin, clopidogrel

If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)

Group Type EXPERIMENTAL

Optimizing ASA and clopidogrel treatment

Intervention Type DRUG

ASA 100 mg, ASA 300 mg, ASA 500 mg

Clopidogrel 75 mg, Clopidogrel 150 mg, Ticlopidine 2x 250 mg, Prasugrel 10 mg. Intervention List:

In the case of clopidogrel low-response, the maintenance dose was doubled (repeated loading dose followed by 150 mg daily), and when still ineffective ticlopidine or prasugrel, if available and not contraindicated, were used. ASA low-responders were treated by increasing the dose to 300 mg in a first step or to 500 mg ASA when the first modification was not sufficient.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optimizing ASA and clopidogrel treatment

ASA 100 mg, ASA 300 mg, ASA 500 mg

Clopidogrel 75 mg, Clopidogrel 150 mg, Ticlopidine 2x 250 mg, Prasugrel 10 mg. Intervention List:

In the case of clopidogrel low-response, the maintenance dose was doubled (repeated loading dose followed by 150 mg daily), and when still ineffective ticlopidine or prasugrel, if available and not contraindicated, were used. ASA low-responders were treated by increasing the dose to 300 mg in a first step or to 500 mg ASA when the first modification was not sufficient.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ASA (aspirin), Clopidogrel (Plavix)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with stable coronary artery disease (CAD) or acute coronary syndromes (ACS) following percutaneous coronary intervention (PCI)

Exclusion Criteria

* abnormal platelet count in patients,
* severe liver disorders,
* current gastrointestinal disorders,
* current infections,
* congestive heart failure,
* known bleeding disorders,
* treatment with bivalirudin or glycoprotein IIb/IIIa antagonists within the last 7 days.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No