COMT on Aspirin Platelets Effects (CAPE) (CAPE)
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|ClinicalTrials.gov Identifier: NCT03433586|
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : December 23, 2020
Specific Aim I: Examine the role of genetic variation in COMT on platelet function in a blinded, randomized, placebo controlled clinical trial of daily placebo or Aspirin (81mg) for 10 ± 3 days. Platelet function will be assessed with platelet aggregometry and by fluorescence-activated cell sorting (FACS) of platelet adhesion molecules P-selectin and GPIIb/IIIa in platelets activated with arachidonic acid, thrombin, collagen, epinephrine and ADP.
Specific Aim II: Examine the effects of platelet releasates harvested at the end of each treatment arm on angiogenesis.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Drug: Aspirin 81 mg Drug: Placebo||Phase 4|
This is a randomized double-blinded, placebo controlled study. This study is designed to detect the variation in platelet function based on COMT variation and how these platelets respond to cancerous cells.
We expect to enroll 100 healthy participants with the intention of studying 90 participants to complete the protocol.
Individuals aged 18 to 40 years will be eligible to participate in this study if they do not have history of fainting/problems related to blood draws, major chronic medical illnesses, regular or current treatment of Aspirin™.
Examine the role of genetic variation in in catechol-O-methyltransferase (COMT) on platelet function in a randomized double-blinded placebo controlled clinical trial of daily Aspirin™ (81 mg) versus placebo over 10-14 days. Platelet function will be assessed with a platelet aggregometry and by fluorescence-activated cell sorting assessment of platelet adhesion molecule GPIIIb/IIIa and p-selectin.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||participants will be randomized to aspirin or placebo|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||COMT on Aspirin Platelets Effects (CAPE)|
|Actual Study Start Date :||July 10, 2020|
|Estimated Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Placebo Comparator: Placebo
Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days
Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days
Active Comparator: Aspirin
Aspirin (81mg) will be taken orally daily for 10-14 days.
Drug: Aspirin 81 mg
81mg of aspirin to be taken daily for 10-14 days
Other Name: acetylsalicylic acid
- platelet aggregation [ Time Frame: At end of treatment 10-14 days the platelets will be activated on the same day as blood collection. ]Platelets will be activated with arachidonic acid, thrombin, collagen, ADP and epinephrine
- % expression of P-selectin on resting and activated platelets [ Time Frame: At end of treatment 10-14 days the platelets will be activated on the same day as blood collection. ]Platelets activated with arachidonic acid, ADP, collagen and epinephrine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433586
|Contact: Kathryn T Hall, PhD||617 278 email@example.com|
|Contact: Elaine Zaharris||617 278 firstname.lastname@example.org|
|Principal Investigator:||Kathryn T Hall, PhD||Brigham and Women's Hospital|